MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LPA2; LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL

Catalog Number	08106126190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for lpa2 on a cobas c 503 analytical unit.The initial result was 32 mg/dl with a data flag.The customer is repeating all samples with high lpa2 results.The repeat results were 27 mg/dl, 19 mg/dl, 19 mg/dl, 20 mg/dl and 20 mg/dl.The repeat results of 19 mg/dl and 20 mg/dl were believed to be correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The field service engineer (fse) completed successful instrument checks and a 21-cup precision test.The fse did not determine a cause for the event.Calibration was last performed on (b)(6) 2023 and was acceptable.Qc was acceptable.There is no indication of a reagent performance issue.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: LPA2
• Common Device Name: LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
• 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: 18158626
• Report Number: 1823260-2023-03645
• Device Sequence Number: 7999499
• Product Code: DFC
• UDI-Device Identifier: 07613336140833
• UDI-Public: 07613336140833
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K122722
• 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): 12/14/2023

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 Expiration Date: 07/31/2024
• Device Catalogue Number: 08106126190
• Device Lot Number: 70551001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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