MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM; SARS-COV-2 REAGENT KIT

Catalog Number 445011

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd sars-cov-2/flu for bd max¿ system lot number indicated on 30 boxes is not the same lot number indicated on the reagent strips.The user realized the boxes had been relabeled.The label on the bottom of the box has the same lot number as the strips but there is no reference to the kit.No patient impact reported.The following information was provided by the initial reporter: the lot indicated on the box (2192582) is not the same as the lot indicated on the reagent strips (2049520).The user realized that the boxes had been relabeled.The label on the bottom has the same lot number as the strips (2049520) but there is no reference to the kit, which is probably why it was relabeled.30 boxes are concerned.The laboratory performed a positive control on one strip.This control was compliant (pos sars-cov-2/pos flu).

Manufacturer Narrative

After additional review, mfr report # 3007420875-2022-00050 was submitted in error.This device is considered exempt.This mdr should be considered canceled.

Event Description

It was reported that bd sars-cov-2/flu for bd max¿ system lot number indicated on 30 boxes is not the same lot number indicated on the reagent strips.The user realized the boxes had been relabeled.The label on the bottom of the box has the same lot number as the strips but there is no reference to the kit.No patient impact reported.The following information was provided by the initial reporter: the lot indicated on the box (2192582) is not the same as the lot indicated on the reagent strips (2049520).The user realized that the boxes had been relabeled.The label on the bottom has the same lot number as the strips (2049520) but there is no reference to the kit, which is probably why it was relabeled.30 boxes are concerned.The laboratory performed a positive control on one strip.This control was compliant (pos sars-cov-2/pos flu).

• Brand Name: BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM
• Type of Device: SARS-COV-2 REAGENT KIT
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15476266
• MDR Text Key: 306267095
• Report Number: 3007420875-2022-00050
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/11/2022
• Device Catalogue Number: 445011
• Device Lot Number: 2049520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1