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

Model Number	R01186
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: BILE ESCULIN AZIDE AGAR W/6UG VANC
• Manufacturer (Section D): REMEL INC; 12076 santa fe trail drive; lenexa KS 66215
• MDR Report Key: 11674661
• Report Number: 1924669-2021-00001
• Device Sequence Number: 19829659
• Product Code: JSO
• UDI-Device Identifier: 00848838000546
• UDI-Public: 00848838000546
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K972359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2021
• Device Model Number: R01186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1