inforMED
MalfunctionPOC

KIT BD MAX CHECK-POINTS CPO IVD

Received Feb 23, 2023 · Event occurred Jan 19, 2023

Report 1119779-2023-00171 · MDR key 16429471

Device

Generic name

See H.10

Catalog number

278102

Lot number

2017254

Product problems

  • False Negative Result
  • False Negative Result

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT USING KIT BD MAX CHECK-POINTS CPO IVD FALSE NEGATIVES HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX CT0488 A5, RUN 2922 - NDM AND VIM POSITIVE. NGS STRAINS CULTURED POSITIVE: KPC, OXA-48, NDM, VIM. FALSE NEGATIVE: KPC AND OXA-48. MAX CT0488 B2, RUN 2933 - ALL NEGATIVE. NGS STRAINS CULTURED POSITIVE: VIM AND OXA-48. FALSE NEGATIVE: VIM AND OXA-48.

Additional Manufacturer Narrative

THE FOLLOWING INFORMATION HAS BEEN UPDATED; B.5. EVENT DESCRIPTION UPDATED TO INCLUDE THE CORRECT BRAND NAME. KIT BD MAX CHECK-POINTS CPO IVD. D.1. MEDICAL DEVICE BRAND NAME: KIT BD MAX CHECK-POINTS CPO IVD. D.4. MEDICAL DEVICE CATALOG #: 278102. D.4. MEDICAL DEVICE LOT # : 2017254. D.4. MEDICAL DEVICE EXPIRATION DATE: 10/07/2022. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-00171 WAS SENT IN ERROR. THE PRODUCT INVOLVED IS NOT SOLD WITHIN THE US AND BD DOES NOT SELL A SIMILAR PRODUCT WITHIN THE US AND/OR IT IS NOT A REGISTERED MEDICAL DEVICE IN THE US. THIS COMPLAINT IS NOT MDR REPORTABLE.

Additional Manufacturer Narrative

COMMON DEVICE NAME: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, ANTIMICROBIAL RESISTANCE MARKER, DIRECT SPECIMEN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT KIT BD MAX CPO FALSE NEGATIVES HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX CT0488 A5, RUN 2922 - NDM AND VIM POSITIVE. NGS STRAINS CULTURED POSITIVE: KPC, OXA-48, NDM, VIM. FALSE NEGATIVE: KPC AND OXA-48. MAX CT0488 B2, RUN 2933 - ALL NEGATIVE. NGS STRAINS CULTURED POSITIVE: VIM AND OXA-48. FALSE NEGATIVE: VIM AND OXA-48.