MODULAR PRE-ANALYTICS EVO B-21 MPA 7 PLUS 739-6721

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for MODULAR PRE-ANALYTICS EVO B-21 MPA 7 PLUS 739-6721 manufactured by Roche Diagnostics.

Event Text Entries

[175677023] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610571
• MDR Report Key: 9610571
• Date Received: 2020-01-21
• Date of Report: 2020-01-09
• Date of Event: 2019-12-19
• Report Date: 2020-01-09
• Date Reported to FDA: 2020-01-09
• Date Reported to Mfgr: 2020-01-21
• Date Added to Maude: 2020-01-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MODULAR PRE-ANALYTICS
• Generic Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Product Code: JQP
• Date Received: 2020-01-21
• Model Number: EVO B-21 MPA 7 PLUS
• Catalog Number: 739-6721
• Device Availability: *
• Device Age: 13 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD INDIANAPOLIS IN 46250 US 46250

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-21