MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT; IMMUNOCHEMISTRY ANALYZER

Model Number E801

Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the elecsys vitamin d gen.2 assay on a cobas 8000 e 801 module.No incorrect results were reported outside of the laboratory.The samples were repeated and the repeat values were deemed correct.The specific date of the event is not known.The event occurred approximately on (b)(6) 2022.The first sample initially resulted in a vitamin d value of > 100 ng/ml.The sample was diluted by the instrument and repeated, resulting in a value of 53 ng/ml and this value was reported outside of the laboratory.The sample was repeated without dilution, resulting in a value of 38 ng/ml.The sample was repeated two more times, each time resulting in a value of 53 ng/ml.No corrected report was issued.The second sample initially resulted in a vitamin d value of > 100 ng/ml accompanied by a data flag on (b)(6) 2022.The sample was repeated with dilution, resulting in a value of 53 ng/ml and this value was reported outside of the laboratory.The sample was repeated without dilution, resulting in a value of 47 ng/ml.No corrected report was issued.The vitamin d reagent lot number was 570755.The reagent expiration date was requested, but not provided.

Manufacturer Narrative

For the last calibration performed on (b)(6) 2022, the calibration signals were lower than expected.Quality controls surrounding the event were within range.Upon review of the alarm trace, sample foam detection and abnormal aspiration alarms occurred on the day of the event.This could be an indication of poor sample quality.The field application specialist reviewed sample handling with the customer.Method comparison studies were performed and were acceptable.The investigation could not identify a product problem.The issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: COBAS E 801 ANALYTICAL UNIT
• 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: 13844488
• MDR Text Key: 294393942
• Report Number: 1823260-2022-00808
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E801
• Device Catalogue Number: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2022
• 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