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	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account generated false elevated alinity c creatinine of 462 umol/l on a patient sample id (b)(6) that repeated 65 umol/l on another analyzer.Historical creatinine patient values ranged 60 to 84 umol/l.No impact to patient management was reported.Patient ethnicity and race were not provided.
Additional Manufacturer Narrative
A device history review was performed for the complaint list number with no nonconformances or deviations found.The trend review by the product list number found no adverse trends and no atypical complaint activity related to this issue.Labeling was reviewed and found to adequately address the issue under review.File sample analysis was not performed as the issue appears to be specific for this patient sample and retesting the same regent lot gave normal results.No customer returns were available for evaluation.No product deficiency 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: 9776631
• Report Number: 3002809144-2020-00159
• Device Sequence Number: 2216860
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/29/2020

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: 03/17/2020
• Device Model Number: 07P9930
• Device Catalogue Number: 07P99-30
• Device Lot Number: 83136UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 04/04/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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 LIST 03R67-01; ALINITY C LIST 03R67-01; SERIAL (B)(4).; SERIAL (B)(4).
• Patient Age: 72 YR