MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN GEN.2; BIURET (COLORIMETRIC), TOTAL PROTEIN

Catalog Number	ASKU
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable alb2 albumin gen.2 and tp2 total protein gen.2 results for one patient from different samples with cobas 8000 c702 module serial numbers(b)(4).The reporter stated the patient¿s albumin level has been slowly declining over the past few days with total protein levels increasing slightly.The customer suspects an interference as the results do not match the clinical picture of the patient.Sample (b)(6): tested on serial number (b)(4).The initial alb result at 11:31 was 4.5 g/l.The repeated result at 12:12 was 4 g/l.The second repeated result at 13:57 was 3.9 g/l.The third repeated result at 14:46 was 4.6 g/l.The tp result was 71.5 g/l.Sample (b)(6): tested on serial number (b)(4) (initial result) and (b)(4) (repeated result) the initial alb result at 19:54 was 3.4 g/l.The repeated result at 22:00 was 4.1 g/l.The tp result was 73.3 g/l.Sample (b)(6): tested on serial number (b)(4).On (b)(6)2021, the alb result was 3.7 g/l.The tp result was 70.8 g/l.The questionable albumin results were not reported outside of the laboratory.It is unknown if the questionable total protein results were reported outside of the laboratory.This medwatch is for tp.Refer to the medwatch with patient identifier (b)(6) for the alb assay.
Additional Manufacturer Narrative
No further information was provided.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TOTAL PROTEIN GEN.2
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13054072
• Report Number: 1823260-2021-03821
• Device Sequence Number: 17439558
• Product Code: CEK
• UDI-Device Identifier: 04015630918928
• UDI-Public: 04015630918928
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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 Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 02/14/2022
• 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