MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problems Circuit Failure (1089); Non Reproducible Results (4029)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

There was a complaint of a questionable (b)(6) combi pt elecsys cobas e 100 v2 result for 1 patient tested with a cobas 8000 c602 module.The questionable result was not reported outside the laboratory.The patient¿s initial result was 0.248; the repeat on (b)(6) 2021 was 1.62.The units of measurement were requested but not provided for all assays.The lot number and expiration date of the (b)(6) combi pt elecsys cobas e 100 v2 used were requested, but not provided.

Manufacturer Narrative

The customer stated there were several abnormal sample probe movement alarms.The field service engineer (fse) discovered a broken wire on the sample probe; the sample probe was replaced.The investigation is ongoing.

Manufacturer Narrative

No further data was provided for investigation; therefore, a detailed investigation of the event is not possible.It is unclear if the broken wire on the sample probe contributed to the discrepant result.The provided information is also consistent with a preanalytical issue.The cause of the event could not be determined.

• Brand Name: COBAS 8000 E 602 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13052363
• MDR Text Key: 290296179
• Report Number: 1823260-2021-03811
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K100853
• 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,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• 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