MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN GEN.2; BIURET TOTAL PROTEIN

Catalog Number	08058652190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable tp2 total protein gen.2 result from one patient sample tested on the cobas pro c 503 analytical unit.The initial result was reported outside of the laboratory.The initial result did not match typical results for this patient as they usually run between 6.7 and 7.2 g/dl.The initial result was 3.4 g/dl.The reporter reran the patient sample 5 times.The repeat result of all 5 reruns was 6.6 g/dl.The repeat results were deemed correct. .
Additional Manufacturer Narrative
The serial number of the customer's cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the qc recovery.The results were within the customer¿s expected ranges.There was no indication of a performance issue with the reagent or instrument.The investigation reviewed the alarm trace.Multiple abnormal aspiration sample pipette alarms were present on the date of the event.Sample short alarms were present as well.This is an indication of possible poor sample quality.The investigation could not determine the exact cause of the event.The investigation determined that the event was consistent with a preanalytical issue at the customer site (abnormal aspiration and short sample alarms in the alarm trace).Based on the information provided, the investigation did not identify a product problem.

• Brand Name: TOTAL PROTEIN GEN.2
• Common Device Name: BIURET 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)
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 17444082
• Report Number: 1823260-2023-02500
• Device Sequence Number: 16822265
• Product Code: CEK
• UDI-Device Identifier: 07613336121528
• UDI-Public: 07613336121528
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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: 08058652190
• Device Lot Number: 71320301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 10/06/2023
• 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