MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBT2; ALBUMIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 08056722190

Device Problems High Test Results (2457); Material Integrity Problem (2978)

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

Event Date 08/12/2023

Event Type  malfunction  

Manufacturer Narrative

The c503 analyzer serial number is (b)(6).

Event Description

The initial reporter complained of a discrepant high result for 1 patient urine sample tested for tina-quant albumin gen.2 (albt2) on a cobas pro c 503 analytical unit.The initial result was 40.1 mg/l.The repeat result was less than 0.583 mg/l with a data flag.

Manufacturer Narrative

Calibration and qc were acceptable.The low albt2 result was believed to be correct.The customer did not provide any additional information for the investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ALBT2
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17662097
• MDR Text Key: 322407146
• Report Number: 1823260-2023-02841
• Device Sequence Number: 1
• Product Code: DCF
• UDI-Device Identifier: 07613336120965
• UDI-Public: 07613336120965
• Combination Product (y/n): Y
• Reporter Country Code: TC
• PMA/PMN Number: K101203
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 08056722190
• Device Lot Number: 617156
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• 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