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	08/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - multiple = (b)(6).There was no additional patient information provided by the customer.A review of tickets determined that there is normal complaint activity for alinity creatinine reagent ln 7p99-20 / lot number 53868un20.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 and another sample were reproducible, indicating a possible issue with the initial sample testing.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the alinity creatinine reagent lot number 53868un20 was identified.
Event or Problem Description
The customer reported falsely elevated alinity c creatinine results on two patients.The results provided were: on (b)(6) 2020 (b)(6) initial = 6.62mg/dl / retest = 6.78 / after physician questioned retest = 2.63 / new sample, same patient = 1.0 / plasma sample from (b)(6) 2020 = 0.91mg/dl; (b)(6) initial = 5.98 / retest = 4.42mg/dl / after physician questioned = 4.01, 3.99mg/dl / new sample, same patient =0.82mg/dl(normal range male= 0.7 - 1.2, female= 0.5 - 0.9mg/dl).There was no reported impact to patient management.

• 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: 10514124
• Report Number: 3002809144-2020-00905
• Device Sequence Number: 2604999
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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
• Report Date (Section B): 09/10/2020

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: 09/18/2021
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 53868UN20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1