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

Model Number MPA

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer questioned results for 3 patient samples tested for ise indirect na, k, ci for gen.2 on a cobas 6000 c (501) module.Based on the data provided, the na and k results for 1 patient were discrepant.The initial na result from an aliquot sample from the c501 module was 148 mmol/l.The initial k result from the aliquot sample was 5.4 mmol/l.This aliquot sample was from the customer's modular pre-analytics (mpa) system.The na result was reported outside of the laboratory where it was questioned by the physician.This medwatch will cover the mpa.(b)(4).On (b)(6) 2018 the sample was loaded manually onto the same c501 module and repeated with an na result of 142 mmol/l and a k result of 5.09 mmol/l with a data flag.The customer also loaded the sample manually onto a different c501 module and the na result was 139 mmol/l and the k result was 4.90 with a data flag.It is not known if the repeat samples were from the aliquot sample or if they were from the primary tube.The repeat results from both c501 modules were believed to be correct.No adverse event occurred.The electrode lot numbers and expiration dates were not provided.The electrodes were changed on (b)(6) 2018 and pinch valve and sipper tubing was replaced on (b)(6) 2018.The customer stated there were no other issues with other tests.On 20-feb-2018 the field service engineer (fse) fse visited the customer site and noted that the drip tray on the mpa was not positioned completely under the sample tip.The bracket was bent slightly and this was re-positioned.The fse performed a leak test for 4 minutes with no dripping.On (b)(6) 2018 the customer complained that the sample tip was getting caught on the drip tray and they were receiving error messages.The fse revisited the customer site on (b)(4) 2018 and found that the drop dish was too high.The fse adjusted the dish to the proper height and tightened the screws on the arm that pulls the drop dish away from the sample tip.A 10-cup specimen run was performed and the instrument operated properly.The customer has not had any additional issues since the service visit on (b)(4) 2018.

Manufacturer Narrative

It was clarified that the repeat results were from the primary tube.The customer performs leak tests daily and stated there was no leaking prior to or after the event.The customer stated the sample tip that was addressed by the fse was the same tip used to aliquot the initial specimen.

Manufacturer Narrative

The investigation determined the misaligned drip tray was the root cause of the event.The issue was resolved after the fse re-aligned the drip tray.When adjustments are done as specified, the drip tray will not become misaligned during normal operation.Product labeling states the drip tray should be checked and cleaned as needed.If further adjustment is needed a roche service representative should be contacted.

Manufacturer Narrative

The customer stated the filters were last replaced on the drip tray arms in (b)(6) 2017.It is not known if the filters were replaced when the fse visited the customer site in feb-2018.The customer stated the filters currently look clean and do not need replacing.

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7327345
• MDR Text Key: 102202597
• Report Number: 1823260-2018-00743
• 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,Followup,Followup
• Report Date: 07/02/2018

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: 02/20/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 02/20/2018; 02/20/2018
• Supplement Dates FDA Received: 03/20/2018; 05/01/2018; 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 93