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 09/05/2018

Event Type  malfunction  

Event Description

The customer noticed that some gray top tubes for glucose were running through the modular pre-analytics (mpa) system and through the analyzer with the cap still on the sample tube.The customer stated the issue was intermittent and has been occurring since (b)(6) 2018.Of approximately 400 gray top sample tubes processed a day, this occurred with between 0-5 sample tubes.The customer alleged that results were produced by the sample even though the cap was still on the tube.When the customer noticed a sample tube with the cap still on, they repeated the sample.The customer provided examples for 2 patient samples.Of the data provided, the results for 1 patient were discrepant.The original glucose result was 157 mg/dl.When the customer repeated the sample after de-capping the tube, the result was 62 mg/dl.The repeat result was believed to be correct.The original result had been reported outside of the laboratory.Once repeat testing was completed, the result was amended.No adverse event occurred.The bar codes for the affected samples were read successfully by the mpa and the samples were sent to the automatic centrifuge (acu) where they were spun successfully.The mpa then sent the samples to the destopper (dsp) where no alarms occurred indicating an issue with uncapping the samples.The samples were then sent to the analyzer for processing instead of the output buffer module (opb) as would happen if alarms had occurred.When the affected sample tubes reached the analyzer, it appeared the samples were skipped.The customer is not sure where the initial glucose results came from.The affected sample tube was not actually processed by the analyzer until the tech manually removed the cap, manually ordered the test and reloaded the sample tube.The customer noted that the affected patient samples were on their pending list of samples.These samples were located in the archive tray with caps on.The customer's process is to remove the gray top sample tubes from the analyzer and archive on the mpa.The results from these patient samples appear to match the results produced from the sample tubes that were originally capped.The field application specialist (fas) visited the customer site and suspects the customer may be re-using sample racks for the gray top glucose samples.The customer may be placing patient samples onto the mpa twice but in different racks.If the first rack gets to the analyzer and the sample bar code is not read, the analyzer queries the middle-ware for the rack/position assignment from the mpa.The sample tube is run and a result is produced for the wrong sample.When the correct sample is placed on the mpa for the 2nd time, the cap is not removed as it thinks the order is complete and only the archive test is pending.These sample racks do not stop at the flexible sample sorter (fss) and are sent directly to the analyzer.The fas found duplicate racks for 29 of the 150 sample racks.It was then discovered that the customer's other campus, which also has an mpa, had sent over the duplicate racks because they were not using them.Some of these racks were put into use.All duplicate racks were removed from use and the customer has not been loading gray sample tubes onto the mpa.Investigations are ongoing.

Manufacturer Narrative

The investigation determined that the issue was due to use error at the customer site.The customer was re-using sample racks which caused the issue with results.The customer has had no further issues since the duplicate racks were removed by the fas.The device did not malfunction.

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7933878
• MDR Text Key: 122660818
• Report Number: 1823260-2018-03425
• 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: 10/15/2018

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: 09/05/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR