MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN/TOTAL PROTEIN STAT; BIURET (COLORIMETRIC), TOTAL PROTEIN

Catalog Number	03183734190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).The competitor method was the alinity method.Qc failed on the current reagent pack; qc passed on the standby reagent pack.The customer replaced the reagent pack and the issue was resolved.Since the issue was resolved by replacing the reagent pack, the investigation determined the event was consistent with an issue with the single reagent pack.Due to the limited information provided, the specific cause of the event could not be determined.
Event or Problem Description
The initial reporter questioned high results for multiple patient samples tested for total protein/total protein stat (tp2) on a cobas 6000 c501 module.The following are examples of discrepant results for 5 patient samples.Patient 1 initial result was 116 g/l.The repeat result was 74.9 g/l.The repeat by a competitor method was 74 g/l.Patient 2 initial result was 101.7 g/l.The repeat result was 64.2 g/l.The repeat by a competitor method was 63 g/l.Patient 3 initial result was 131 g/l.The repeat result was 76.5 g/l.The repeat by a competitor method was 77 g/l.Patient 4 initial result was 138.7 g/l.The repeat result was 79.9 g/l.The repeat by a competitor method was 80 g/l.Patient 5 initial result was 113.1 g/l.The repeat result was 69.1 g/l.The repeat by a competitor method was 69 g/l.The initial results were reported outside of the laboratory.The samples were repeated as the results were higher than expected.

• Brand Name: TOTAL PROTEIN/TOTAL PROTEIN STAT
• Common Device Name: BIURET (COLORIMETRIC), TOTAL PROTEIN
• 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: 18939310
• Report Number: 1823260-2024-00814
• Device Sequence Number: 7026910
• Product Code: CEK
• UDI-Device Identifier: 04015630918928
• UDI-Public: 04015630918928
• Combination Product (Y/N): Y
• Initial Reporter Country: EI
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

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: 03183734190
• Device Lot Number: 750118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/20/2024
• 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