MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN URINE/CSF GEN.3; TURBIDIMETRIC, TOTAL PROTEIN

Model Number	TPUC G3
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was a complaint of questionable total protein urine/csf gen.3 results for 1 patient tested with two cobas 8000 c502 modules.The cobas 8000 c502 module serial numbers were (b)(4).The sample type was urine.The patient¿s initial result on module a was 100 mg/l; the repeat was 100 mg/l.The patient¿s initial result on module b was 100 mg/l; the repeat was 100 mg/l.The patient¿s sample was tested on an unspecified competitor's analyzer via a qualitative test and received a negative result.The patient¿s sample was tested with a pyrogallol red method and received a result of 7 mg/l.It is unknown if the questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
The investigation results and the customer results are comparable and within the expected range.A reagent issue can be excluded.The investigation found the observed differences are consistent with the underlying differences in test principles.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The customer stated they had provided the incorrect units of measurement as "mg/l" initially.The correct units of measurement are mg/dl.Please refer to the attached data for updated customer results.The patient's complained sample was investigated by the manufacturer.Please refer to the attached data.

• Brand Name: TOTAL PROTEIN URINE/CSF GEN.3
• Common Device Name: TURBIDIMETRIC, 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: 12746163
• Report Number: 1823260-2021-03205
• Device Sequence Number: 4471336
• Product Code: JGQ
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141925
• Number of Events Summarized: 1
• Summary Report (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,Followup
• Report Date (Section B): 12/16/2021

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 Model Number: TPUC G3
• Device Catalogue Number: 03333825190
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 12/02/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 11/29/2021; 12/16/2021
• 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