MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2; IGM (MU CHAIN SPECIFIC) TEST

Catalog Number 08057923190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The field service engineer (fse) determined that the analyzer is operating properly.The investigation is ongoing.

Event Description

There was an allegation of questionable igm-2 tina-quant igm gen.2 results for 1 patient sample on a cobas pro c 503 analytical unit.The initial igm result was 43 mg/dl.The customer was having issues with proficiency samples which prompted them to rerun qc and calibration, as well as perform a patient sample comparison.The sample was repeated the next day and the result was 31.3 mg/dl.

Manufacturer Narrative

Calibration was last performed on (b)(6) 2024.The alarm trace showed sample foam, sample clot, sample probe, and abnormal aspiration errors.The investigation did not identify a product problem.The root cause of the event could not be determined.

Manufacturer Narrative

The medical coding for this case was updated.

• Brand Name: ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
• Type of Device: IGM (MU CHAIN SPECIFIC) TEST
• 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: 18712682
• MDR Text Key: 336225003
• Report Number: 1823260-2024-00452
• Device Sequence Number: 1
• Product Code: DAO
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K040431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08057923190
• Device Lot Number: 716688
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1