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

Model Number MPA

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Event Description

The initial reporter stated that some samples were bypassing the centrifuge and going directly to the aliquoter of the modular pre-analytics system (mpa).The issue occurred intermittently.The customer stated that based on this, they started centrifuging samples without using the mpa.The customer stated that they received questionable test results for three patient samples that were processed on the system.Of these, one had erroneous results for ise indirect na for gen.2 and gluc3 glucose hk gen.3 that were reported outside of the laboratory.The sample was processed on the mpa and then tested on an unknown roche clinical chemistry analyzer, resulting with an na value of 130 mmol/l accompanied by a data flag.The sample was repeated, resulting with a value of 141 mmol/l.A corrected report was issued with the repeat value.The sample was processed on the mpa and then tested on an unknown roche clinical chemistry analyzer, resulting with a gluc3 value of 125 mg/dl accompanied by a data flag.The sample was repeated, resulting with a value of 78 mg/dl.A corrected report was issued with the repeat value.The patient was not adversely affected.The na electrode and gluc3 reagent lot numbers and expiration dates were asked for, but not provided.The field service engineer determined there was an electronic failure of a sensor on the mpa.He inspected all racks to ensure they were being routed correctly in the system and all checked out ok.He replaced the failed sensor.He restarted the instrument to normal operation.The customer loaded samples and no errors were observed.The customer later called back and stated that the issue has returned as system was still routing samples past the centrifuge.The field service engineer returned and checked the system.He could not determine a cause and could not re-produce the issue.He checked the alarm history and there was no associated hardware alarm.He performed temperature and operational checks.

Manufacturer Narrative

The sensor on the mpa goes into use after the sample has passed the automated centrifuge unit.The sensor is not the root cause of the event.The mpa was excluded as the source of the failure.The investigation did not exclude an operator or user error.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8447498
• MDR Text Key: 139713060
• Report Number: 1823260-2019-01217
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

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
• Initial Date Manufacturer Received: 03/10/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 03/10/2019
• Supplement Dates FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR