MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHOL2; ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Catalog Number	05168538190
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	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 cobas c 701 module is (b)(6).The serum patient sample is suspected to have a high concentration of ascorbic acid.The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable trigl triglycerides and chol2 cholesterol gen.2 results from one patient sample tested on the cobas 8000 cobas c 701 module.This mdr is for the chol2 assay.Please refer to mdr with a1.Patient identifier (b)(6) for the trigl assay.The reported complained that the patient sample had chol2 and trigl results close to zero but the hdl-c and ldl-c totaled to over 100 mg/dl (hdl = 52 mg/dl; ldl = 53 mg/dl).The physician did not believe the results because they could not be correct and were incompatible with life.The reporter stated that there is an interference due to the therapy of paracetamol intoxication indicated in the four assays mentioned and also another interference for the chol2 and trigl assays.On (b)(6) 2024: the initial chol2 result was <10 mg/dl.The first repeat result was <10 mg/dl.On (b)(6) 2024: the second repeat result was <10 mg/dl.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation sent the patient sample to another laboratory and was tested for triglycerides and cholesterol using a competitor assay and analyzer.The results are: triglycerides - 74 mg/dl cholesterol - 13 mg/dl the investigation determined that the triglycerides assay from the competitor analyzer contains ascorbic acid oxidase; the result is acceptable and probably correct.The investigation determined that the cholesterol assay from the competitor analyzer does not contain ascorbic acid oxidase; the assay's cholesterol result is probably falsely low and is comparable to roche's cholesterol results.The investigation determined that the event was caused by an interferent (patient sample suspected to have a high concentration of ascorbic acid).Trigl product labeling states "exception: ascorbic acid and calcium dobesilate cause artificially low triglyceride results.Intralipid is directly measured as analyte in this assay and leads to high triglyceride results.The investigation did not identify a product problem.

• Brand Name: CHOL2
• Common Device Name: ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
• 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: 18776411
• Report Number: 1823260-2024-00538
• Device Sequence Number: 18238523
• Product Code: CHH
• UDI-Device Identifier: 04015630924967
• UDI-Public: 04015630924967
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K031824
• 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): 04/22/2024

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: 05168538190
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 04/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALLOPURINOL 200; AMIODARON 200; ATORVASTATIN 40; CLOPIDOGREL 75; EPLERENON; ISOPROLOL 5; ISOTRETINOIN 5; KALINOR RETARD; L-THYROXIN 75; PANTOZOL B. BED.; TILIDIN 50/4; TORASEMID 20
• Patient Sex: Unknown