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MalfunctionGKZ

BD MULTITEST¿

Received Oct 27, 2023 · Event occurred Oct 10, 2023

Report 2916837-2023-00209 · MDR key 18017513

Device

Generic name

Counter, Differential Cell

Catalog number

644611

Lot number

42267

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings
  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD MULTITEST¿ ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TBNK RUN WITH 1/3 OF PATIENTS SHOWING A SMALL PERCENTAGE OF CONTAMINATION. TBNK LOT 42267 EXP 30.06.2024, THIS BOTTLE WAS THE 1ST BOTTLE OF 8 WHICH WAS OPENED ON 29.09.23 FOR PRE-TESTING. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (ANSWER: YES). 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (ANSWER: NO). 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (ANSWER: N/A, PATIENT SAMPLES NOT REDRAWN.) 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (ANSWER: NO).

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES G.1 - REPORTING OFFICE CONTACT - (B)(4) G.1 - MANUFACTURING SITE CONTACT - (B)(4). H6. INVESTIGATION SUMMARY: BD ACKNOWLEDGES THE CUSTOMER'S EXPERIENCE REGARDING THE INDICATED FAILURE MODE, CUSTOMER OBSERVED A CD3+CD8+CD4- SMALL POPULATION DIMMER THAN THE CD8+ CLUSTER IN THE CD3/CD8 DOT PLOT WITH 6-COLOR BNK REAGENT PART 644611-42267. THE CAUSE OF THE REPORTED ISSUE OF A CD3+CD8+ SCATTERED EVENTS OBSERVED TO BE DIMMER THAN THE CD3+CD8+ CLUSTER POPULATION WAS NOT DETERMINED. THE ISSUE CAN BE DUE TO THE STICKINESS OF THE APC-CY7 TANDEM FLUOROPHORE USED TO CONJUGATE TO CD8 ANTIBODY. THE MATERIAL PASSED ALL THE PRODUCT SPECIFICATION WHEN RELEASE. PERFORMANCE CHECK OF THE COMPLAINT LOT WAS COMPARED TO A REFERENCE LOT AND BOTH LOTS PERFORMED COMPARABLY. BD IS CONTINUALLY MONITORING COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUES TO IDENTIFY EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD MULTITEST¿ ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TBNK RUN WITH 1/3 OF PATIENTS SHOWING A SMALL PERCENTAGE OF CONTAMINATION. TBNK LOT 42267 EXP 30.06.2024, THIS BOTTLE WAS THE 1ST BOTTLE OF 8 WHICH WAS OPENED ON 29.09.2023 FOR PRE-TESTING. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (ANSWER: YES) 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (ANSWER: NO) 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (ANSWER: N/A, PATIENT SAMPLES NOT REDRAWN) 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (ANSWER: NO).