ROCHE MPA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for ROCHE MPA manufactured by Roche.

Event Text Entries

[95760783] Beginning in (b)(6) 2017 through (b)(6) 2017, there were 5 instances where a set of 5 samples appeared to be missing, but were found on the roche mpa. In working with the vendor it was eventually determined that since the lab has 2 mpa instruments that racks from mpa 1 were being used on mpa2. These racks are identical including the bar code numbers with the exception of a green sticker for mpa. When the second rack with the same bar code number is introduced to the analyzer and the first rack with the same number is currently being processed, the analyzer will produce an error message that indicates "rack and pos is already occupied by another sample. " the instrument allows the operator to override the error and re-introduce the rack. The instrument than disassociates the first set of pt demographics and replaces it with the second set of pt demographics, thereby testing the 1st set of samples and applying the second set of pt demographics to the result. This cause 22 results to be reported on the incorrect pts.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5074195
• MDR Report Key: 7142245
• Date Received: 2017-12-21
• Date of Report: 2017-12-20
• Date Added to Maude: 2017-12-22
• Event Key: 0
• Report Source Code: Voluntary 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: 0

Device Details

• Brand Name: ROCHE
• Generic Name: MPA (MYCOPHENOLIC ACID ASSAY)
• Product Code: DLJ
• Date Received: 2017-12-21
• Model Number: MPA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE
• Manufacturer Address: BASEL, CH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-12-21