MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA; CLINICAL CHEMISTRY ANALYZER

Model Number MPA

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2018

Event Type  malfunction  

Event Description

The customer questioned high sodium (na) results and low co2 results for multiple patients tested on a cobas 6000 c (501) module.The customer provided data for 25 patient samples tested for na.Based on the data provided, the results for 14 patient samples are a reportable malfunction.The repeat results were run on a different analyzer.The initial results were reported outside of the laboratory.The repeat results from the different analyzer were believed to be correct.No adverse event occurred.The na reagent lot number and expiration date were not provided.The customer stated the issue is noticed mainly during busy time of the day.The customer thinks the issue is due to evaporation of the patient samples during the wait time to run on the c501 module after being aliquoted from the modular pre-analytics (mpa) system.The customer doesn't think there is any issue with the c501 module as they performed a correlation to another instrument and the results compared well to one another.The customer has started batching samples in smaller amounts to decrease the wait time for the samples to get to the c501 module.The field service engineer (fse) visited the customer site and there were no calibration or qc issues.The issue was only occurring with samples coming from the mpa.Patient samples with high priority immunology tests are taking longer to be sampled allowing evaporation to occur.This evaporation causes the higher na results.The primary tube samples that are front-loaded onto the c501 module are producing correct results.The aliquot groups on the mpa may need to be re-configured so that separate aliquots can be made for chemistry and immunology tests.This should allow chemistry samples like na to be processed faster reducing the chance for evaporation.

Manufacturer Narrative

Qc results were acceptable.Multiple abnormal reagent probe movement messages were observed on the alarm trace data.The field service engineer (fse) found an issue with the ise block.The ise block and ise degasser were replaced.The instrument then operated within specification.The customer ran qc on the c501 module.

Manufacturer Narrative

The issue was solved by changing the instrument's software configuration.The customer has had no further issues since the service visit.

Manufacturer Narrative

Further investigation determined the root cause of the issue was the delay in patient samples from the modular pre-analytics (mpa) system and not the the ise block and ise degasser on the c501 instrument as originally determined by the investigation.Applicable fields of sections d and g were corrected.The field application specialist (fas) visited the customer site and examined the aliquot group configuration settings.The fas changed the alternation ratio as well.The customer had the mpa configured to run serum indices tests on all immunoassay samples.The customer decided to remove this configuration to decrease the delay in patient samples being tested.Changing the alternation ratio and removing the serum indices testing vastly reduced the delays in samples being tested.The customer monitored these changes for several days and the situation improved.

• Brand Name: MPA
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7867962
• MDR Text Key: 119949955
• Report Number: 1823260-2018-03086
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• 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,Followup,Followup
• Report Date: 11/07/2018

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: 08/23/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 08/23/2018; 08/23/2018; 08/23/2018
• Supplement Dates FDA Received: 09/25/2018; 10/29/2018; 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR