MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA EVO; CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE

Model Number C501

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received a questionable ise indirect na for gen.2 result for one patient sample with the cobas 6000 c 501 module.The initial result was 99 mmol/l.The repeated result was 99 mmol/l.A new sample was taken with a result of 140 mmol/l.The original sample was tested on a b221 with a result of 143 mmo/l.The questionable result was reported outside of the laboratory.The electrode lot number was l0938.The expiration date was requested but not provided.

Manufacturer Narrative

The investigation ruled out an instrument-related problem and found that the samples had been processed on a modular pre-analytics (mpa) system.Error data and log files from the mpa were reviewed.Preventive maintenance had been performed on the mpa.It was confirmed that the customer discards all hitachi cups that have been through the mpa/cobas to ensure no cups are being used twice.The customer has had no further issues.The investigation did not identify a product problem.The cause of the event could not be determined.Medwatch fields d1-4, g1 and g4 have been updated.

• Brand Name: MPA EVO
• Type of Device: CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12656564
• MDR Text Key: 279933167
• Report Number: 1823260-2021-03037
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: EXEMPT
• 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: 11/16/2021

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
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 04993551001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 11/16/2021
• 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