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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX SA FOSFOMYCIN FM 1024 US B30

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BIOMÉRIEUX SA FOSFOMYCIN FM 1024 US B30 Back to Search Results
Catalog Number 529140
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A customer in the usa notified biomérieux of obtaining qc failure (out-of-range-high results) in association with fosfomycin fm 1024 us b30 - (ref: 529140, lot 1008857310, expiration date 17/07/2022) regarding an atcc® strain. They reported both lot 1008857310 and 1008200670 were not passing qc for pseudomonas aeruginosa atcc® 27853¿: the expected mic results were between 2 and 8 and the customer is getting 32. They reran the test six different times and stated they still did not get the correct result. This complaint is against the lot 1008857310. The customer retested the strain following the methodology and storage guidance provided by biomérieux and the qc with atcc 27853 is still out of range high (mic of 12-16-24, instead of 2-8). No delayed results related to this qc failure have been reported by the customer. As there is no patient associated with this qc strain, there is no adverse event related to any patient's state of health. A biomérieux internal investigation will be created.
 
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Brand NameFOSFOMYCIN FM 1024 US B30
Type of DeviceFOSFOMYCIN FM 1024 US B30
Manufacturer (Section D)
BIOMÉRIEUX SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer (Section G)
BIOMÉRIEUX SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
jeff scanlan
595 anglum road
hazelwood, MO 63042
MDR Report Key12955064
MDR Text Key285538955
Report Number9615754-2021-00289
Device Sequence Number1
Product Code JWY
UDI-Device Identifier03573026256739
UDI-Public03573026256739
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981136
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/17/2022
Device Catalogue Number529140
Device Lot Number1008200670
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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