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

Catalog Number	05168538190
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable chol2 cholesterol gen.2, elecsys total psa immunoassay, and iron2 iron gen.2 results from 1 patient on a cobas 8000 cobas c 701 module.The customer was unable to obtain plausible results from 1 patient's samples.The dates of testing were (b)(6) 2022.All samples gave a result of "???" for all tests except for iron on (b)(6) 2022.The result was requested but not provided.It is suspected that there may be an interfering factor in the patient sample.No questionable results were reported outside of the laboratory.The analyzer serial number is (b)(4).This medwatch will cover cholesterol.Refer to medwatch with patient identifier (b)(6) for information on the psa results and medwatch with patient identifier (b)(6) for information on the iron results.
Additional Manufacturer Narrative
Electrophoresis testing was performed on one of the samples.The results show a high concentration of gamma-globulins which indicates a possible gammopathy.It was found that the sample on (b)(6) 2022 did not produce results due to a clogged needle indicated by an alarm flag.The investigation found that proteinemia, most likely caused by the high concentration of gamma-globulins, is the cause of elevated viscosity of the samples, which caused sample needle blockage.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15503359
• Report Number: 1823260-2022-02974
• Device Sequence Number: 18175939
• Product Code: CHH
• UDI-Device Identifier: 04015630924967
• UDI-Public: 04015630924967
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

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 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): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 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
• Concomitant Medical Products and Therapy/Usage Dates: ASS.
• Patient Sex: Unknown