MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA; AUTOMATED PREANALYTICAL SYSTEM

Model Number MPA

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

Error data and log files from the instrument were reviewed.The rack with the barcode was checked at the customer site and no issues were identified.The field application specialist (fas) performed aliquoter checks and no issues were identified.It was confirmed that the customer discards all cups from an aliquot rack before re-using the aliquoter on the mpa instrument.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of discrepant results for 2 patient samples processed through the evo b-11dr mpa (modular pre-analytics) 7 plus instrument.An aliquot from the patient was processed through the mpa and the results did not match the previous results for this patient.The customer pulled the primary tube and repeated it and the results between the aliquot sample and the primary tube were discrepant.Patient 1 results from the aliquot were: na: 139 mmol/l, total protein: 5.7 g/dl.Patient 1 repeat results from the primary tube were: na: 132 mmol/l, total protein: 4.6 g/dl.Patient 2 results from the aliquot were: ck: 737 u/l, creatinine: 1.01 mg/dl, tnt: 0.288 ng/ml.Patient 2 repeat results from the primary tube were: ck: 12 u/l, creatinine: 0.60 mg/dl, tnt: <0.01 ng/ml.Questionable results were reported outside of the laboratory.No reagent lot numbers with expiration dates were provided.The analyzers in use were: ise module with serial number (b)(4), cobas 8000 c 702 module with serial number (b)(4), cobas 8000 c 502 module with serial number (b)(4), cobas 8000 e 602 module with serial number (b)(4).

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• 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: 10830264
• MDR Text Key: 215948655
• Report Number: 1823260-2020-02863
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2020

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: MPA
• Device Catalogue Number: 05005256002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/12/2020
• 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