MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TOTAL PROTEIN

Catalog Number	05171954190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c702 analyzer is (b)(6).The reaction data from the analyzer was checked and for the initial value, it appears that a high dose hook effect is likely.The initial repeat, 1:3, and 1:5 dilution reactions appeared unstable.The 1:2 dilution value had decreasing absorbance at the end of the reaction.Calibration and controls were acceptable, so a general reagent issue can be ruled out.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient urine sample tested with total protein urine/csf gen.3 on a cobas 8000 c702 module.The sample initially resulted in a total protein value of 3064 mg/l accompanied by a data flag indicating high absorbance.The sample was automatically repeated, resulting in a value of 1152 mg/l.The sample was diluted 1:2 and repeated, resulting in a raw total protein value of 1591 mg/l which was calculated to a final value of 3182 mg/l.The sample was diluted 1:3 and repeated, resulting in a raw total protein value of 931 mg/l which was calculated to a final value of 2793 mg/l.The sample was diluted 1:5 and repeated, resulting in a raw total protein value of 415 mg/l which was calculated to a final value of 2075 mg/l.The sample was diluted 1:10 and repeated, resulting in a raw total protein value of 104 mg/l which was calculated to a final value of 1040 mg/l.
Additional Manufacturer Narrative
The customer stated there was no evidence of gammopathy in the patient.The customer stated that the 1:3 dilution was performed as an automatic repeat by the analyzer.The customer stated that dilutions were performed twice manually by different operators and the results were comparable.Medwatch field d10 has been updated.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The 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: 20009474
• Report Number: 1823260-2024-02388
• Device Sequence Number: 7201599
• Product Code: JGQ
• UDI-Device Identifier: 04015630925179
• UDI-Public: 04015630925179
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 12/13/2024

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: 07/31/2025
• Device Catalogue Number: 05171954190
• Device Lot Number: 79939500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 12/04/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 11/27/2024; 12/13/2024
• 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: CONTRACEPTIVE PILL CERAZETTE; CORTISONE; DAPAROX; ESOMEPRAZOL; FREMANEZUMAB; INFLIXIMAB; PAROXETIN; TRIPTAN
• Patient Sex: Unknown