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

Catalog Number	06L45-42
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
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.Section a1 patient identifier sids: (b)(6) , (b)(6).
Event or Problem Description
The customer reported falsely elevated total bilirubin results generated on the architect c16000 analyzer on two patients that were not reported out of the laboratory.The following results were provided: sid (b)(6) = 4.72 mg/dl repeated on another architect = normal (no result provided) sid (b)(6) = 9.38 mg/dl repeated on another architect = normal (no result provided) normal range: 0.2 - 1.2 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 62807uq09.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.The customer confirmed that after an onsite intervention by a technician, no more false elevated results have occurred.Based on the investigation, no deficiency of the architect total bilirubin reagent lot number 62807uq09 was identified.
Event or Problem Description
The customer reported falsely elevated total bilirubin results generated on the architect c16000 analyzer on two patients that were not reported out of the laboratory.The following results were provided: sid (b)(6) = 4.72 mg/dl repeated on another architect = normal (no result provided).Sid (b)(6) = 9.38 mg/dl repeated on another architect = normal (no result provided).Normal range: 0.2 - 1.2 mg/dll; 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17912737
• Report Number: 3002809144-2023-00427
• Device Sequence Number: 18016721
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: 00380740174972
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 12/22/2023

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: 02/29/2024
• Device Catalogue Number: 06L45-42
• Device Lot Number: 62807UQ09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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 C16K REFURB-SEKAT, 03L77-97, (B)(6) ; ARC C16K REFURB-SEKAT, 03L77-97, (B)(6)
• Patient Sex: Unknown