MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE

Model Number	07P9930
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
An evaluation is in process.A followup report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely elevated creatinine result generated on the alinity c analyzer on one patient.Results provided: (b)(6) 2020, sid (b)(6) = 428 umol/l, repeated on another alinity c on (b)(6) 2020 = 83 umol/l.Reference range: male (63.6 - 110.5 umol / l) female (50.4 - 98.1 umol / l).No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for alinity creatinine ln 7p99 lot 82385un19.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.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 ln 7p99 lot 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: 10181512
• Report Number: 3002809144-2020-00493
• Device Sequence Number: 19596499
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• 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): 07/07/2020

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: 07P9930
• 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: 06/22/2020
• Supplement Report FDA Received Date: 07/07/2020
• 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 LIST 03R67-01; ALINITY C PROCESSING MODULE LIST 03R67-01; SERIAL (B)(6); SERIAL (B)(6)