MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TOTAL PROTEIN

Catalog Number	05171954190
Medical Device Problem Codes	Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable total protein (tpuc3) results for one patient from the cobas 8000 c702 module compared to another c702 module.The initial results were 50.0 mg/dl and 51.43 mg/dl.The repeat results on another c702 module were 33.0 mg/dl and 33.9 mg/dl.The repeat results from another c702 module in another laboratory were 48 mg/dl and 49 mg/dl.
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
D4 expiration date was updated.A general reagent issue was excluded since calibration and qc data were acceptable.An interference was unlikely because the reaction monitor for the discrepant result was inconspicuous.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• Brand Name: TPUC3
• Common Device Name: 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: 18685456
• Report Number: 1823260-2024-00395
• Device Sequence Number: 6249520
• Product Code: JGQ
• UDI-Device Identifier: 04015630925179
• UDI-Public: 04015630925179
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: K071239
• 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,Followup
• Report Date (Section B): 04/12/2024

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: 05171954190
• Device Lot Number: 750333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FEBURIC TAB; FOICHOL TAB; GODEX CAP; KAROS SUSPENSION; LACIDOFIL CAP; LASIX TAB; POLYBUTINE SR TAB; URSA TAB
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Race: Asian