MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA CHOLESTEROL GEN. 2; CHOLESTEROL, ENZYMATIC

Catalog Number	08057443190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with chol2 cholesterol gen.2 on cobas pro c 503 analytical unit serial number (b)(4).The sample initially resulted in a cholesterol value of 702 mg/dl and this value was reported outside of the laboratory to the doctor.The doctor requested a repeat of the sample.The sample was repeated, resulting in a value of 261 mg/dl.The sample was also repeated on a second analyzer, resulting in a value of 260 mg/dl.
Additional Manufacturer Narrative
The field application specialist repeated samples tested around the same time as the complained sample and these repeated ok.The sample probe and washer were checked; the cell rinse water levels were ok.A drop of water was found at a cell cover that covers the incubator bath filter.The cuvettes and lamp screws were checked and these were tight.The cell covers, sample probes and reagent probes were cleaned.Probe wash and air purge maintenance items were performed.Precision studies were performed for multiple parameters and only cholesterol precision was outside of specifications.The field service engineer reduced the cell rinse water volume.Maintenance was performed on the analyzer, including cleaning the incubator bath, replacing the lamp, and replacing the cuvettes.Precision studies were performed.Controls were run and passed.The sample that was previously pipetted into the same cuvette used to measure the complained sample had a high cholesterol result.This plasma sample was milky.
Additional Manufacturer Narrative
The questioned sample was aliquoted and refrigerated on (b)(6) 2023 and the sample appeared lipemic and without white material.Precision studies were performed with the sample on (b)(6) 2023 and white material was found in the sample before and after it was centrifuged.The following cholesterol values were obtained with the complained sample during the precision study: 415 mg/dl, 221 mg/dl, 96.4 mg/dl with a data flag, 95.2 mg/dl with a data flag, 94.5 mg/dl with a data flag, 94.3 mg/dl with a data flag, 93.8 mg/dl with a data flag, 94.4 mg/dl with a data flag, 93.8 mg/dl with a data flag, 93.9 mg/dl with a data flag, 94.8 mg/dl with a data flag, 95.5 mg/dl with a data flag, 95.0 mg/dl with a data flag, 94.5 mg/dl with a data flag, 95.3 mg/dl with a data flag, 94.2 mg/dl with a data flag, 95.5 mg/dl with a data flag, 94.6 mg/dl with a data flag, 94.7 mg/dl with a data flag, 94.7 mg/dl with a data flag, 94.3 mg/dl with a data flag, 95.9 mg/dl with a data flag, 94.8 mg/dl with a data flag.
Additional Manufacturer Narrative
Based on calibration and quality control recovery, a general product issue can be excluded.The alarm trace showed an abnormal aspiration alarm on (b)(6) 2023.This could indicate an issue with pre-analytic sample handling.A hardware check test was within specifications.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: COBAS INTEGRA CHOLESTEROL GEN. 2
• Common Device Name: CHOLESTEROL, ENZYMATIC
• 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: 16708536
• Report Number: 1823260-2023-01179
• Device Sequence Number: 12217739
• Product Code: CHH
• UDI-Device Identifier: 07613336121115
• UDI-Public: 07613336121115
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Followup
• Report Date (Section B): 08/04/2023

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: 08/31/2023
• Device Catalogue Number: 08057443190
• Device Lot Number: 67702501
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 07/26/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 04/28/2023; 08/04/2023
• 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