MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MODULAR PRE-ANALYTICS; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number EVO B-21 MPA 7 PLUS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 12/19/2019

Event Type  malfunction  

Event Description

From staff: one morning the pharmacy called to inquire about questionable results on this patient, particularly the creatinine and blood urea nitrogen (bun).Patient has had an elevated bun and creatinine and on this morning the results were reported as normal.The lab began an investigation and was able to manually load this sample and results then matched previous.Found that there were 10 total patients affected over the two mornings of the same day and the next day.The same issue occurred with a rack of patient samples, 5 per rack, 1 rack per day, so 10 patients in total affected.Both times this occurred the 5 patients' sample in the rack got aliquoted and associated with a different 5 patients.Testing equipment was fine, and we found no issues.This was isolated to the mpa, any samples we front-loaded on the testing equipment came out with no issue.Manufacturer response for roche diagnostics front-end automation, modular pre-analytics (per site reporter).Roche diagnostics established a case number.Roche was very quick in their response and has completed a thorough initial investigation to our satisfaction.Roche will also be reporting this incident to the fda.The root cause of this issue appeared to be that two yellow mpa centrifuge racks had the identical serial number which caused this issue.This particular technology requires specific use of uniquely number racks and someone a duplicate ended up on the instrument at the exact same time, leading to erroneous test results for 10 patients.

• Brand Name: MODULAR PRE-ANALYTICS
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9610571
• MDR Text Key: 175677023
• Report Number: 9610571
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2020

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: No Information
• Device Model Number: EVO B-21 MPA 7 PLUS
• Device Catalogue Number: 739-6721
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2020
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 62