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

Model Number MPA

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier: (b)(4).

Event Description

The customer complained of questionable results for several patient samples tested for elecsys testosterone ii assay (testo) on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer that had the initial samples processed by a modular pre-analytical system (mpa).The customer stated that they had to repeat several samples of which some did not match.The customer provided the testosterone data for only 1 patient.This medwatch will cover the mpa.Refer to medwatch with patient identifier (b)(6) for information on the e170 module.The patient's initial testo result of 77 ng/dl with a repeat result of 120 ng/dl.The initial result was from an aliquot processed through the mpa while the repeat result was from the primary tube being loaded onto the analyzer.The repeat result was deemed to be correct.The erroneous results were released outside of the laboratory.There were no adverse events.The testosterone reagent lot was 23299404 with an expiration date of 31-aug-2018.The field engineering specialist was unable to find a root cause.He checked the mpa operation and verified that their were no abnormal splashes and/or carry over.The customer's leak check passed on the day of event.The field engineering specialist verified the systems operations and the instrument is considered in good working order.

Manufacturer Narrative

The customer has had no new complaints of a similar nature.

Manufacturer Narrative

Further investigation based on the available information found the issue was not related to the modular pre-analytical system (mpa).The investigation was unable to find a definitive root cause.

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7320691
• MDR Text Key: 102124362
• Report Number: 1823260-2018-00695
• Device Sequence Number: 0
• Product Code: CDZ
• 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
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• 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
• Date Manufacturer Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1