MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATINE KINASE

Model Number	08P4220
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2020
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely decreased creatine kinase (ck) result generated on the alinity c analyzer on one patient.Results provided: on (b)(6) 2020 sid (b)(6) = 95.6 u/l, repeated at 95 u/l, another laboratory = > 1000.It was noted that the sample was lipemic and the ck result was obtained post centrifugation for 5 minutes / 10,000 rpm.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for creatine kinase (ck) reagent ln 8p42 lot number 11776un20.Trending review determined no trends for falsely decreased results for the product.Return testing was not completed as returns were not available.A repeat test on the patient sample at the customer site produced an acceptable result.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 creatine kinase (ck) reagent ln 8p42 lot number 11776un20 was identified.

• Brand Name: ALINITY C CREATINE KINASE
• Common Device Name: CREATINE KINASE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10326205
• Report Number: 3002809144-2020-00730
• Device Sequence Number: 11628904
• Product Code: JLB
• UDI-Device Identifier: 00380740132590
• UDI-Public: 00380740132590
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/04/2020

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: 11/13/2020
• Device Model Number: 08P4220
• Device Catalogue Number: 08P42-20
• Device Lot Number: 11776UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 08/04/2020
• 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)