MAUDE Adverse Event Report: ABBOTT GMBH TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	06L45-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely decreased total bilirubin result generated on the architect c4000 analyzer for one pediatric patient.A new sample was drawn and the result was lower.The customer repeated with original sample with a lower result.The following data was provided: processed on (b)(6) 2023 sid (b)(6) initial result = 0.5 repeat result on same sample = 6.3.New sample sid (b)(6) = 6.3.Normal range for pediatric = 0.2-8.0 mg/dl.Earlier result from (b)(6) 2023 = 8.9 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier: sid (b)(6) and sid (b)(6).
Additional Manufacturer Narrative
Trending review determined no trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.The sample in question was retested by the customer and gave an acceptable result.In addition, quality control was performing as expected.No additional issues were identified.Based on the investigation, no deficiency for lot number 63648uq02 was identified.Additional information and update to section b5 describe event or problem.Repeat was a higher result and result and sid explanation added.
Event or Problem Description
The customer observed a falsely decreased total bilirubin result generated on the architect c4000 analyzer for one pediatric patient.A new sample was collected and ran and the result was higher.The customer repeated the original sample with a higher result.The following data was provided: sid (b)(6) initial result = 0.5 repeat result on same sample = 6.3 new sample sid (b)(6) = 6.3 normal range for pediatric = 0.2-8.0 mg/dl earlier result from (b)(6) 2023 = 8.9 mg/dl updated information provided (b)(6) 2023 = customer states sid when scanned on the instrument is shorter but last 8 alphanumeric numbers are the same.Sid on instrument ¿(b)(6)¿ repeat result on same sample was 6.37 and on new sample was 6.32 no impact to patient management was reported.

• Brand Name: TOTAL BILIRUBIN
• 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: 17425240
• Report Number: 3002809144-2023-00334
• Device Sequence Number: 14965971
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: 07/31/2024
• Device Catalogue Number: 06L45-22
• Device Lot Number: UNKNOWN
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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: ARC C4000 INTGR, 02P24-40, C402037; ARC C4000 INTGR, 02P24-40, C402037
• Patient Sex: Unknown