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

Catalog Number 08057923190

Device Problem Non Reproducible Results (4029)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable roche diagnostics tina-quant igm gen.2 results for 1 patient on a cobas c 503 analytical unit.The initial result was 38 mg/dl.On (b)(6) 2024 and (b)(6) 2024 the sample was repeated and the results were 13 mg/dl both times.The repeated results are believed to be correct.The sample was initially repeated due to qc being out of specification after the result was obtained.The initial result was reported outside of the laboratory and later corrected.

Manufacturer Narrative

The analyzer serial number is (b)(6).The customer refused a field service call.The investigation is ongoing.

Manufacturer Narrative

Sections d1-d3, g1, and g4 were updated.The field service representative replaced and adjusted the sample probe.He replaced the piercer and made adjustments.Abnormal aspiration alarms were noted which strongly indicate an insufficient preanalytical handling issue.The qc data show the drift behavior but is within specifications.The analysis shows a module running within specification.

• 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: 18815386
• MDR Text Key: 336635523
• Report Number: 1823260-2024-00613
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 71668801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• 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