MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGL; TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL

Catalog Number	05171407190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon initial investigation of reaction data, the reaction monitors for low values show abnormal kinetics which may be related to oxygen depletion, causing the kinetics to decrease at the end of the run.A > kin flag is an indicator for extremely high triglyceride concentrations in the sample.Precision studies were performed and the results were ok.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with trigl triglycerides on a cobas 8000 c (701) module.The sample initially resulted in a triglycerides value of 391 mg/dl and this result was reported outside of the laboratory to the doctor.The doctor complained about the value since it did not fit with values from other lipid tests.The sample was repeated on (b)(6) 2022, resulting in a value of 133.5 mg/dl.As this value also did fit with other values, the sample was repeated again.The sample was repeated a second time on (b)(6) 2022, resulting in a value of 965.8 mg/dl accompanied by a >kin data flag, indicating unstable reaction kinetics.The sample was automatically repeated at decreased sample volume, resulting in a value of 4180.4 mg/dl.The sample was repeated a third time on (b)(6) 2022, resulting in a value of 1302.9 mg/dl accompanied by a > abs data flag, indicating high absorbance.The sample was automatically repeated at decreased sample volume, resulting in a value of 4138.9 mg/dl.As the values were abnormal, the customer re-centrifuged the sample at a higher speed and repeated the sample a fourth time on (b)(6) 2022, resulting in a value of > 1415.8 mg/dl accompanied by a data flag.The sample was automatically repeated at decreased sample volume, resulting in a value of 2875.3 mg/dl.The 2875.3 mg/dl value was believable and fit with the patient's results.The serial number of the customer's c 701 analyzer is (b)(4).
Additional Manufacturer Narrative
Control data was within range.Calibration data from the last calibration on 22-jul-2022 was ok.The reaction curves of the low sample results show that there is an oxygen depletion during the assay reaction, leading to falsely low results.Per product labeling: "prozone check: the flag > kin is an indicator for extremely high triglyceride concentrations in the sample.False normal results are due to oxygen depletion during assay reaction.Precision studies were ok, except for one of 5 test parameters.
Additional Manufacturer Narrative
The customer stored the sample frozen.The sample was thawed and re-tested.The sample was repeated and resulted in an unknown value that was accompanied by a >kin data flag.The sample was repeated again, resulting in an unknown value accompanied by a > abs data flag.The sample was then repeated again, resulting in an expected value of > 4000 mg/dl.

• Brand Name: TRIGL
• Common Device Name: TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15266885
• Report Number: 1823260-2022-02519
• Device Sequence Number: 20477336
• Product Code: CDT
• UDI-Device Identifier: 04015630925117
• UDI-Public: 04015630925117
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K873049
• 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): 09/29/2022

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: 06/30/2023
• Device Catalogue Number: 05171407190
• Device Lot Number: 644461
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 08/18/2022; 09/07/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/06/2022; 09/29/2022
• 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