MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CYSC2; 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	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable tina-quant cystatin c gen.2 (cysc2) results from one patient sample tested on the cobas 8000 c702 module.The initial result was reported outside of the laboratory.The doctor complained that the result did not match the patient's history and health status and the rest of the diagnostic test results, prompting the rerun of the patient sample.The reporter also serially diluted the patient sample with 0.9% nacl manually to check for any interference.On (b)(6) 2023: - the initial result of the undiluted patient sample was 6.25 mg/l.On (b)(6) 2023: - the first repeat result of the undiluted patient sample was 6.35 mg/l.- the second repeat result with the patient sample at 1:16 dilution was 0.00 mg/l.- the third repeat result with the patient sample at 1:8 dilution was 0.10 mg/l with a final dilution result of 0.80 mg/l.- the fourth repeat result with the patient sample at 1:4 dilution was 0.31 mg/l with a final dilution result of 1.24 mg/l.- the fifth repeat result with the patient sample at 1:2 dilution was 1.42 mg/l with a final dilution result of 2.84 mg/l.- the sixth repeat result of the undiluted patient sample was 6.59 mg/l.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation tested the patient sample for the following immunoglobulin assays: iga, igm, igg, kappa, and lambda.The results for iga and igg were below the normal range; the igm result was above the normal range; the kappa/lambda ratio was above the normal range.The investigation concluded that all of the immunoglobulin assay results were highly pathological.The patient sample was tested further using the cobas c 702 and cysc2 retention kits.The test was performed with the patient sample diluted with water (product labeling states "sample dilution diluent (h2o").The results obtained by the investigation were comparable with the results obtained by the customer; the investigation excluded a general reagent issue.The investigation determined that the cause of the event was consistent with a known interferent in the patient sample (due to gammopathy).Product labeling states "in very rare cases, gammopathy, in particular type igm (waldenstrom¿s macroglobulinemia), may cause unreliable results.In very rare cases falsely elevated results for cystatin c will be obtained from samples taken from patients who have been treated with rabbit antibodies or have developed anti-rabbit antibodies.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.

• Brand Name: CYSC2
• 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: 17641221
• Report Number: 1823260-2023-02796
• Device Sequence Number: 7936637
• Product Code: NDY
• UDI-Device Identifier: 04015630932405
• UDI-Public: 04015630932405
• Combination Product (Y/N): Y
• 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): 10/10/2023

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 06600263190
• Device Lot Number: 70545001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/10/2023
• 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