MAUDE Adverse Event Report: ABBOTT GMBH CREATININE; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	3L81-23
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated creatinine results on one patient generated on the architect analyzer.The results provided were: (b)(6).There was no reported impact to patient management.
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer due to privacy issues.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for creatinine list number 3l81, lot 06557un20.Trending review determined no trends for discrepant patient results for the product.Return testing was not completed as returns were not available.Retesting of the sample at the customer site gave expected results.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Device history record review did not identify any non-conformances or deviations with lot 06557un20 and the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the architect creatinine, lot 06557un20 was identified.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• Brand Name: CREATININE
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11747992
• Report Number: 3016438761-2021-00164
• Device Sequence Number: 4357475
• Product Code: CGX
• UDI-Device Identifier: 00380740161552
• UDI-Public: 00380740161552
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 02/27/2022
• Device Model Number: 3L81-23
• Device Catalogue Number: 03L81-23
• Device Lot Number: 06557UN20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 06/07/2021
• 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 C8 PROC MOD, 01G06-11, C802605; ARC C8 PROC MOD, 01G06-11, C802605