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

Catalog Number 05168538190

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 306274221
• Report Number: 1823260-2022-02974
• Device Sequence Number: 1
• Product Code: CHH
• UDI-Device Identifier: 04015630924967
• UDI-Public: 04015630924967
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05168538190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASS.