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

Catalog Number	08106126190
Medical Device Problem Codes	High Test Results (2457); Chemical Problem (2893); Improper Chemical Reaction (2952); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with lpa2 (lipoprotein a) on a cobas pro c 503 analytical unit.No questionable results were reported outside of the laboratory.The customer had been running samples in duplicate due to ongoing issues.The sample initially resulted in a lipoprotein a value of > 67 mg/dl accompanied by a data flag.The sample was repeated with a x3 automatic dilution, resulting in a lipoprotein a value of 63 mg/dl.The sample was repeated a second time, resulting in a lipoprotein a value of 131 mg/dl.The sample was repeated three additional times, resulting in lipoprotein a values of 71 mg/dl, 65 mg/dl, and 65 mg/dl.The sample was repeated twice on a second analyzer, resulting in lipoprotein a values of 73 mg/dl and 64 mg/dl.The sample was repeated two additional times on the second analyzer on 16-oct-2023, resulting in lipoprotein a values of 66 mg/dl and 63 mg/dl.The value of 63 mg/dl was deemed correct.
Additional Manufacturer Narrative
The last calibration performed on 19-sep-2023 was ok and there were no alarms.Quality controls recovered within range.There was no indication of a reagent or instrument performance issue.The field service engineer stated that previous instrument checks passed.Precision studies were performed and these recovered within acceptable ranges.The investigation could 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: 18144316
• Report Number: 1823260-2023-03617
• Device Sequence Number: 7609633
• 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): 12/13/2023

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: 08106126190
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/13/2023
• 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