MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT CYSTATIN C GEN. 2; CREATININE TEST SYSTEM

Catalog Number	06600263190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable cysc tina-quant cystatin c results for 1 patient sample on a cobas 8000 c702 module.The initial cysc result was 7.95 mg/l accompanied by a flag indicating the value is above the linearity/measuring range of the assay.The customer questioned the result as it did not correspond with the patient's creatinine result.The sample was repeated in decrease mode and the result was 9.09 mg/l.The sample was repeated again and the result was 7.96 mg/l accompanied by a flag indicating the value is above the linearity/measuring range of the assay.A 1:3 dilution of the sample was performed and the result was 1.60 mg/l.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).An interfering factor is suspected in the patient sample.The investigation is ongoing.
Additional Manufacturer Narrative
It was determined that the patient is diagnosed with waldenström macroglobulinemia.Per product labeling, "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results." the investigation did not identify a product problem.

• Brand Name: TINA-QUANT CYSTATIN C GEN. 2
• Common Device Name: CREATININE TEST SYSTEM
• 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: 20641191
• Report Number: 1823260-2024-03240
• Device Sequence Number: 20675042
• Product Code: NDY
• UDI-Device Identifier: 04015630932405
• UDI-Public: 04015630932405
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141143
• 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): 12/06/2024

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 Catalogue Number: 06600263190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/23/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/06/2024
• 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
• Patient Age: 64 YR
• Patient Sex: Male