MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT LIPOPROTEIN (A) GEN.; 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	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable tina-quant lipoprotein (a) gen.2 (lpa2) results 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 in duplicate.On (b)(6) 2024: the initial result from the line 2 was 48 mg/dl.The first repeat result from line 2 was 57 mg/dl.The second repeat result from line 1 was 30 mg/dl.On (b)(6) 2024: the third repeat result from line 1 was 30 mg/dl.The result of 30 mg/dl was reported.
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on 13-jan-2024; the results were within specifications.The investigation reviewed the qc recovery.The recovery was within -2 standard deviations (sd) nd within specifications.There was no indication of a performance issue with the reagent.The investigation reviewed the customer's handling of patient samples.The patient sample was centrifuged for 5.5 minutes at 2160 rpm.The centrifugation time may be too short and the speed may be too low according to the tube manufacturer¿s recommended guidelines.The investigation reviewed the alarm trace.There were multiple sample foam detection, sample clot detection, and sample short alarms noted on the date of the event close to the time the patient sample was processed.The field service engineer (fse) inspected the analyzer and was not able to determine the cause of the event.He also did not detect any hardware problems.He performed a 21-cup precision assay using qc material with acceptable results.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.

• Brand Name: TINA-QUANT LIPOPROTEIN (A) GEN.
• 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: 19032282
• Report Number: 1823260-2024-01018
• Device Sequence Number: 18184591
• 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): 05/15/2024

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: 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: 03/11/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/15/2024
• 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