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

Catalog Number	08106126190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas pro c 503 analytical unit is (b)(6).The field service engineer (fse) inspected the analyzer and was not able to detect any problems.He then performed instrument checks and a 21-cup precision check with successful results.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable tina-quant lipoprotein (a) gen.2 (lpa2) results from two patient samples tested on the cobas pro c 503 analytical unit.The reporter was able to provide one patient sample with discrepant results.The initial result was not reported outside of the laboratory.The patient sample was rerun on their other cobas pro analyzer.The initial result from the analyzer was (b)(6) with a data flag.The first repeat result from the analyzer was (b)(6) with a data flag.The second repeat from the other analyzer result was (b)(6) with a data flag.The third repeat result from the other analyzer was (b)(6) with a data flag.The repeat results from the other analyzer were deemed correct. .
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on (b)(6) 2023; the results were within specifications.The investigation reviewed the qc recovery; the qc recovery was within the customer¿s established range.There was no indication of a performance issue with the reagent or instrument.However, the qc recovery did not cover the date of the event.The alarm trace was requested but not provided.The customer stated that one of the samples had a sample clot flag in one of the reruns and that they removed the clot from the patient sample after it was flagged.The investigation reviewed the customer's handling of patient samples; the patient samples were centrifuged for 5.5 minutes at 2160 rpm.The centrifugation time may be too short and the speed may be too low as per the tube manufacturer¿s recommended guidelines.After service, no further issues were reported by the customer.The investigation determined the service actions verified the analyzer's performance and the issue was resolved.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: 18578951
• Report Number: 1823260-2024-00223
• Device Sequence Number: 7852930
• 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

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: 06/30/2021
• Device Catalogue Number: 08106126190
• Device Lot Number: 44754801
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 01/25/2024
• 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