MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 501 MODULE; ALBUMIN IMMUNOLOGICAL TEST SYSTEM

Model Number C501

Device Problems High Test Results (2457); High Readings (2459)

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

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation found high, out-of-range qcs.The customer decided not to proceed with any further investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

There was a complaint of questionable albumin results for 1 patient tested with a cobas 6000 c501 module.The questionable results were not reported outside the laboratory.The sample type was urine.The patient¿s initial result was 51.7 mg/l; the repeat was 13.3 mg/l.A second repeat was tested on (b)(6) 2021 and resulted in 2.5 mg/l and was accompanied by a data flag.This result was from a fresh aliquot of the sample.The lot number of albumin used was 550468 and the expiration date was requested, but not provided.

Manufacturer Narrative

The specific albumin reagent used was requested, but not provided.The reagent cassette was changed and new calibration was run.No general reagent issue was identified.No further issues have been reported.

• Brand Name: COBAS C 501 MODULE
• Type of Device: ALBUMIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12780538
• MDR Text Key: 280600430
• Report Number: 1823260-2021-03297
• Device Sequence Number: 1
• Product Code: DCF
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 04745914001
• Device Lot Number: 550468
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1