MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE

Model Number	07P9920
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no further patient information provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated creatinine on alinity c processing module for multiple patients.The results were provided: on (b)(6) 2020 sid (b)(6) creatinine=177 umol/l on (b)(6) 2020 repeated on another alinity =98 umol/l(% difference=81%) (laboratory reference range for men=63.6 to 110.5 umol/l and women=50.4 to 98.1 umol/l).There was no reported impact to patient management.
Additional Manufacturer Narrative
An investigation was performed for the customer issue and included a review of the complaint text, troubleshooting, a search for similar complaints, instrument service history review, and a review of product labeling.A review of tickets was performed for alinity creatinine reagent lot number 82385un19.The ticket search found no complaints similar to this issue.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the creatinine assay lot number 82385un19 was identified.

• Brand Name: ALINITY C CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10203144
• Report Number: 3002809144-2020-00533
• Device Sequence Number: 1074173
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (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): 07/08/2020

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: 03/04/2021
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 82385UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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 PROCESSING MODULE; ALINITY C PROCESSING MODULE; LIST # 03R67-01, SERIAL # (B)(6); LIST # 03R67-01, SERIAL # (B)(6)