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

Catalog Number	04V51-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated alinity c total bilirubin and provided the following data for a newborn baby (age and premature/full term status unk): on (b)(6) 2024 at 5:35 pm ,sample id (b)(6), initial result was 389.1 umol/l, which generated a high result flag.The customer reported that because of elevated result phototherapy was provided.After 2 hours of phototherapy, the child was sent to another facility and a new sample for total bilirubin (platform unknown) generated a result of 213 umol/l.The patient¿s physician questioned the results and asked to have sample id (b)(6) repeated (approximately 14 hours later).The repeat results on (b)(6) 2024 were 231.6, 233.8, 244.4 umol/l, which all results generated high result flags.The sample was stored at a temperature +4°c and exposed to only the light from the lab.There were no reported injuries or patient harm and no reported impact on patient management.
Event or Problem Description
The customer reported falsely elevated alinity c total bilirubin and provided the following data for a newborn baby (age and premature/full term status unk): on (b)(6) 2024 at 5:35 pm sample id (b)(6) initial result was 389.1 umol/l, which generated a high result flag.The customer reported that because of elevated result phototherapy was provided.After 2 hours of phototherapy, the child was sent to another facility and a new sample for total bilirubin (platform unknown) generated a result of 213 umol/l.The patient¿s physician questioned the results and asked to have sample id (b)(6) repeated (approximately 14 hours later).The repeat results on (b)(6) 2024 were 231.6, 233.8, 244.4 umol/l, which all results generated high result flags.The sample was stored at a temperature +4°c and exposed to only the light from the lab.There were no reported injuries or patient harm and no reported impact on patient management.
Additional Manufacturer Narrative
The complaint investigation 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.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any associated non-conformances or deviations with the complaint lot.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.Ticket trending review has not identified any trends.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the alinity c total bilirubin reagent lot number 64384uq06.
Event or Problem Description
The customer reported falsely elevated alinity c total bilirubin and provided the following data for a newborn baby (age and premature/full term status unk): on (b)(6) 2024 at 5:35 pm sample id (b)(6) initial result was 389.1 umol/l, which generated a high result flag.The customer reported that because of elevated result phototherapy was provided.After 2 hours of phototherapy, the child was sent to another facility and a new sample for total bilirubin (platform unknown) generated a result of 213 umol/l.The patient¿s physician questioned the results and asked to have sample id (b)(6) repeated (approximately 14 hours later).The repeat results on (b)(6) 2024 were 231.6, 233.8, 244.4 umol/l, which all results generated high result flags.The sample was stored at a temperature +4°c and exposed to only the light from the lab.There were no reported injuries or patient harm and no reported impact on patient management.
Additional Manufacturer Narrative
Section d4 - primary udi number was corrected.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18913385
• Report Number: 3002809144-2024-00075
• Device Sequence Number: 6886581
• Product Code: CIG
• UDI-Device Identifier: 00380740158422
• UDI-Public: (01)00380740158422(17)241130(10)64384UQ06
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/10/2024

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: 11/30/2024
• Device Catalogue Number: 04V51-31
• Device Lot Number: 64384UQ06
• 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: 03/10/2024
• Supplement Date Received by Manufacturer: 04/25/2024; 05/09/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 05/02/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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: ALNTY C PROCESSING MODU, 03R67-01, AC04805; ALNTY C PROCESSING MODU, 03R67-01, AC04805; ALNTY C PROCESSING MODU, 03R67-01, AC04805
• Patient Sex: Unknown