MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C TOTAL BILIRUBIN REAGENT KIT; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	04V51-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated alinity c total bilirubin results in newborns.The customer states that they received complaints from medical centers and the customer is currently sending these samples to their partner laboratory for testing.The customer provided one example: on (b)(6): newborn sample (4 days old at time of testing), sid (b)(6): alinity total bilirubin result = 16.11 mg/dl.Roche total bilirubin result = 12.8 mg/dl.The customer states for their young patients would have to go under the uv lamp for such high values or have further blood draws.It is not known whether this specific patient received uv lamp treatment or had additional blood draws.There was no further impact to patient management reported.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity c total bilirubin results while using the alinity c bilirubin calibrator included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.A review of customer data aligned with the customer¿s issue and no additional issues were identified.A ticket search by product lot number 60667fd01 did not identify an increase in complaint activity for the current issue.The trend review by the product list number (08p61-01) found no related trends for the product for the issue.The review of the device history records did not identify any non-conformances or deviations related to the lot number 60667fd01 and the complaint issue.Labeling was reviewed and found to be adequate for the issue under review.As part of the troubleshooting, the samples were repeated on another methodology analyzer and generated lower results.No issues with the quality control (qc) results were observed.Lot number 60667fd01 met expected release criteria and the product continues to perform within specifications.However, a notification letter was provided to customers to explain that there is the potential for a shift in recovery in total bilirubin and direct bilirubin results when using the alinity c bilirubin calibrator kit (ln 08p61-01) lot 60667fd01.Based on the investigation, no systemic issue or product deficiency of the alinity c total bilirubin assay or alinity c bilirubin calibrator kit lot 60667fd01 were identified.
Event or Problem Description
The customer reported falsely elevated alinity c total bilirubin results in newborns.The customer states that they received complaints from medical centers and the customer is currently sending these samples to their partner laboratory for testing.The customer provided one example: on (b)(6) 2023: newborn sample (4 days old at time of testing), sid (b)(6): alinity total bilirubin result = 16.11 mg/dl.Roche total bilirubin result = 12.8 mg/dl.The customer states for their young patients would have to go under the uv lamp for such high values or have further blood draws.It is not known whether this specific patient received uv lamp treatment or had additional blood draws.There was no further impact to patient management reported.
Event or Problem Description
The customer reported falsely elevated alinity c total bilirubin results in newborns.The customer states that they received complaints from medical centers and the customer is currently sending these samples to their partner laboratory for testing.The customer provided one example: on (b)(6) 2023: newborn sample (4 days old at time of testing), sid (b)(6): alinity total bilirubin result = 16.11 mg/dl.Roche total bilirubin result = 12.8 mg/dl.The customer states for their young patients would have to go under the uv lamp for such high values or have further blood draws.It is not known whether this specific patient received uv lamp treatment or had additional blood draws.There was no further impact to patient management reported.
Additional Manufacturer Narrative
Updated a1 - patient identifier: (b)(6) (complete sample id, exceeded the allowable characters in the field) all available patient information was included.Additional patient details are not available.Updated d4 - primary udi number from (b)(4).To accommodate new version of emdr form.H10 - additional mfg narrative (legacy) has been modified to incorporate the corrected information in h11 - additional mfg narrative (new version of emdr form).It was noted that a notification letter was inadvertently referenced in the final report.To clarify the intent of that statement, a notification letter was not provided to the customer, but rather an email response providing details of the complaint investigation.No other information required correction.The conclusion remains the same that no systemic issue or product deficiency was identified.The complaint investigation for falsely elevated alinity c total bilirubin results while using the alinity c bilirubin calibrator included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.A review of customer data aligned with the customer¿s issue and no additional issues were identified.A ticket search by product lot number 60667fd01 did not identify an increase in complaint activity for the current issue.The trend review by the product list number (08p61-01) found no related trends for the product for the issue.The review of the device history records did not identify any non-conformance's or deviations related to the lot number 60667fd01 and the complaint issue.Labeling was reviewed and found to be adequate for the issue under review.As part of the troubleshooting, the samples were repeated on another methodology analyzer and generated lower results.No issues with the quality control (qc) results were observed.Lot number 60667fd01 met expected release criteria and the product continues to perform within specifications.A response was provided to the customer to explain the outcome of the investigation for this event involving the alinity c bilirubin calibrator kit (ln 08p61-01) lot 60667fd01.Based on the investigation, no systemic issue or product deficiency of the alinity c total bilirubin assay or alinity c bilirubin calibrator kit lot 60667fd01 was identified.

• Brand Name: ALINITY C TOTAL BILIRUBIN REAGENT KIT
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17814668
• Report Number: 3002809144-2023-00409
• Device Sequence Number: 11348593
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: (01)00380740158415(17)240930(10)64054UQ04
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 04V51-21
• Device Lot Number: 64054UQ04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 08/06/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 12/07/2023; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINITY C BILIRUBIN CAL, 08P61-01, (B)(6); ALINITY C BILIRUBIN CAL, 08P61-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Age: 4 DA
• Patient Sex: Unknown