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

Catalog Number	08106126190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 73658701.The expiration date is 31-dec-2024.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable tina-quant lipoprotein (a) gen.2 (lpa2) result from one patient sample tested on the cobas pro c 503 analytical unit.The initial result was not reported outside of the laboratory.The reporter stated they rerun the patient samples for the assay at least in duplicate.The reported line is line 1.The initial result from the line 1 was 81 mg/dl.The first repeat result from line 1 was 54 mg/dl.The second repeat result from line 2 was 49 mg/dl.The third repeat result from line 2 was 49 mg/dl.The fourth repeat result from line 1 was 49 mg/dl.The fifth repeat result from line 1 was 49 mg/dl.This result was deemed correct. .
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The field service engineer (fse) inspected the analyzer and was unable to determine the cause of the event.He then performed an instrument check and a 21-cup precision check using pooled serum; all of the results were acceptable.He determined that the system checks did not indicate any hardware issues.The investigation reviewed the qc recovery; the qc recovery was within the customer's provided range.There was no indication of a performance issue with the reagent.The investigation reviewed the calibration data; the customer uses the auto-calibration feature and would perform reagent pack calibration after 24 hours if the qc dictates.The investigation reviewed the analyzer's log files.The following findings were noted: the qc recovery showed a coefficient of variation (cv) of up to 4%, sometimes with low results but within the specified range.The alarm trace showed frequent "abnormal aspiration" errors for the s1 sample probe.The customer had different cassettes on board at the same time and the customer calibrates each cassette.The investigation determined that the event was not caused by a general or systematic instrument or reagent issue.The investigation did not identify a product problem.

• 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 46250-0457
• MDR Report Key: 18702935
• Report Number: 1823260-2024-00434
• Device Sequence Number: 3326027
• 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): 03/08/2024
• 2 Devices were Involved in the Event: 1 2

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: 12/31/2024
• Device Catalogue Number: 08106126190
• Device Lot Number: 73658701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/08/2024
• 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