MAUDE Adverse Event Report: REMEL INC REMEL; BILE ESCULIN AZIDE AGAR W/6UG VANC

Model Number R01186

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

Customer reports breakthrough growth of negative qc strain e.Faecalis 29212 during qc testing.Customer states it's growing better than the positive strain e.Faecalis atcc 51299 and has the blackening.Lot number 237214 was set up side by side with same bug and performed as expected.Later, the customer reported they used new cultiloop of e.Faecalis 29212 (lot #929106 exp 7/29/21).Customer performed retest qc using 0.5 mcfarland of the qc organism along with a 1:10 and 1:100 dilution of the 0.5 mcfarland.All three failed qc.The new lot of bile esculin azide #255981 passed qc.No patient impact was reported.

Manufacturer Narrative

Retain samples of the complaint lot were set against a comparison lot.The reported lot, comparison lot, and viability lot plates were set following the inspection plan procedure in duplicate with e.Faecalis atcc 29212 and e.Coli atcc 25922 using a mcf 0.5 dilution and e.Faecalis atcc 51299 using a 1:100 dilution.A 10^-5 backtiter was set for all viability plates.All the plates were incubated at 33-37c in ambient atmosphere for 24 hours on top of the plate rack (per ip).The complaint was confirmed as complaint lot had good growth with blackening for e.Faecalis atcc 29212.A review of the batch record was also completed.Further review indicated an incorrect raw material was added.

• Brand Name: REMEL
• Type of Device: BILE ESCULIN AZIDE AGAR W/6UG VANC
• Manufacturer (Section D): REMEL INC; 12076 santa fe trail drive; lenexa KS 66215
• MDR Report Key: 11674661
• MDR Text Key: 280547011
• Report Number: 1924669-2021-00001
• Device Sequence Number: 1
• Product Code: JSO
• UDI-Device Identifier: 00848838000546
• UDI-Public: 00848838000546
• Combination Product (y/n): N
• PMA/PMN Number: K972359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2021
• Device Model Number: R01186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1