MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALANINE AMINOTRANSFERASE ACC. TO IFCC W/ PYRIDOXAL PHOSPHATE ACTIVATION; ALT/SGPT TEST

Catalog Number	08056773190
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure c303 analytical unit serial number was (b)(6).Qc was within range on the day of the event.The investigation is ongoing.
Event or Problem Description
We received an allegation about altp results for 5 patients' serum samples not matching the altp results in heparinized plasma samples tested on a cobas pure c303 analytical unit.Sample 1 (patient 1): serum result: 72.2 u/l.Plasma result: 66.1 u/l.Sample 2 (patient 2): serum result: 21.1 u/l.Plasma result: 15.6 u/l.Sample 3 (patient 3): serum result: 91.2 u/l.Plasma result: 86.8 u/l.Sample 4 (patient 4): serum result: 25.3 u/l.Plasma result: 19.3 u/l.The customer was planning to switch from performing tests in serum tubes to heparin tubes and this was what prompted the repeat of the samples.No questionable results were reported outside the laboratory.The serum results were considered to be correct.On (b)(6) 2024: sample 5 (patient 5): serum result: 25.5 u/l.Plasma result: 17.6 u/l.The customer suspected potential interference between the anticoagulant.
Additional Manufacturer Narrative
The alarm trace showed multiple abnormal aspiration reagent pipette alarms and abnormal aspiration sample pipetter/sample probe alarms.This indicates preanalytical issues.The field service engineer performed general maintenance and detected that the system was underfilled with the wash solution.He then performed a hardware check on 08-jan-2025 with acceptable results.The investigation did not identify a product problem.The root cause was consistent with a pre-analytical handling issue at the customer site.Preanalytics are within the customer's responsibility.

• Brand Name: ALANINE AMINOTRANSFERASE ACC. TO IFCC W/ PYRIDOXAL PHOSPHATE ACTIVATION
• Common Device Name: ALT/SGPT TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21018745
• Report Number: 1823260-2024-03816
• Device Sequence Number: 17173894
• Product Code: CKA
• UDI-Device Identifier: 07613336120989
• UDI-Public: 07613336120989
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K954992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: 10/31/2025
• Device Catalogue Number: 08056773190
• Device Lot Number: 81382201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown