MAUDE Adverse Event Report: ROCHE DIAGNOSTICS APOAT; ALPHA-1-LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	08105448190
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); No Apparent Adverse Event (3189); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with apoat (apolipoprotein a) on a cobas pro c 503 analytical unit.No questionable results were reported outside of the laboratory.The sample initially resulted in an apolipoprotein a value of 94 mg/dl.The value was considered very high so the sample was repeated.The repeat apoliporotein a result was 45 mg/dl.The sample was also repeated twice on a second analyzer on (b)(6) 2023, resulting in apoliporotein a values of 36 mg/dl and 36 mg/dl.The results from the second analyzer were deemed correct.
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).The field service engineer ran precision studies and these recovered within guidelines.The investigation is ongoing.
Additional Manufacturer Narrative
Quality controls recovered within range.There was no indication of a reagent performance issue.The field service engineer ran precision studies and these recovered within guidelines.An instrument check was performed and it recovered within specifications.Frequent abnormal aspiration errors were observed on the alarm trace.The investigation did not identify a product issue.The cause of the event could not be determined.

• Brand Name: APOAT
• Common Device Name: ALPHA-1-LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM
• 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: 18007436
• Report Number: 1823260-2023-03428
• Device Sequence Number: 20750527
• Product Code: DER
• UDI-Device Identifier: 07613336133521
• UDI-Public: 07613336133521
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K013249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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 Catalogue Number: 08105448190
• Device Lot Number: 705510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 12/11/2023
• 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