MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C PROCESSING MODULE; AUTOMATED CHEMISTRY ANALYZER

Model Number	07P9920
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 elevated creatinine result generated on the alinity c analyzer on one patient.Results provided: sid 500010630 = 2.934 / 1.99 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from alinity c creatinine, list number 07p99-20 in section d of this report to alinity c processing module, list number 03r67-01.Manufacturing site of new suspect device is the same as previous one.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
During the subsequent site visit by the field service engineer (fse) the analyzer was inspected, and part replacement and cleaning was performed.Return testing was not completed as returns were not available.A review of the analyzer service history identified no contributing factors to the current complaint.There have been no further occurrences of discrepant results after the service activity was performed by the fse.The alinity ci series operations manual addresses sample result observed problems for erratic/discrepant results.A review of the clinical chemistry systems tracking and trending data revealed no systemic issues or trends associated with the discrepant result described in this complaint.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Based on the investigation no product deficiency was identified.

• Brand Name: ALINITY C PROCESSING MODULE
• Common Device Name: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9520943
• Report Number: 3002809144-2019-01088
• Device Sequence Number: 10911405
• Product Code: JJE
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• 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,Followup
• Report Date (Section B): 01/20/2020

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 Model Number: 07P9920
• Device Catalogue Number: 03R67-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/06/2020; 01/17/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/15/2020; 01/20/2020
• 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 CREATININE LIST 07P99-20; ALINITY C CREATININE LIST 07P99-20; ALINITY C PROCESSING MODULE LIST 03R67-01; LOT UNKNOWN; LOT UNKNOWN; SERIAL (B)(4)