MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) KIT GRP A STREP 30 TEST VERITOR; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Catalog Number 256040

Device Problem False Positive Result (1227)

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

Event Date 08/18/2023

Event Type  malfunction  

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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in sparks, md has been listed in sections d.3.And g.1.And the sparks fda registration number has been used for the manufacture report number.D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.

Event Description

It was reported that while using kit grp a strep 30 test veritor they had false positive ¿ all other assays except bactec media bottles the following was rpeorted by the initial reporter: patient 2 of 2 it was reported by the customer that they had discrepant results customer states they have been observing some discrepant results since (b)(6) 2021, however they never report anything, until this morning in which they observed 1 patient that according to the doctors, had symptoms and they observed two lines in the cartridge but the analyzer gave a negative result, customer wasn't very sure about the results obtained once this test was repeated, first she stated a negative and then a positive result, requesting this info again by email, since she stated that this info needed to be confirmed by the techs that perform the tests.For this patient a culture was requested, and the doctors decided to hold the treatment until culture confirmation.She also spoke about 2 siblings the las week in which one of them had a negative result and the other one a positive result with the veritor analyzer, was confirmed by culture a negative result, and the treatment was stopped.No adverse event reported for this medication change.

Manufacturer Narrative

Investigation summary: this statement summarizes the investigation results regarding a complaint that alleges ¿discrepant results¿ when using kit grp a strep 30 test veritor (material # 256040), batch number 3128261.The customer reported that they had been observing some discrepant results since october 2021, however they did not report anything until this morning when they observed 1 patient.According to the doctors the patient had symptoms and when performing the test, they observed two lines in the cartridge, but the analyzer gave a negative result.The customer was not sure about the results obtained.When this test was repeated, initially it showed a negative result, and then it displayed a positive result.For this patient a culture was requested, and the doctors decided to hold the treatment until culture confirmation.The customer also mentioned about 2 siblings the last week, where one received a negative result and the other a positive result using the veritor analyzer.This was confirmed by culture test, which showed a negative result, and the treatment was stopped.No adverse event reported for this medication change.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing were performed on the batch number provided.The results were acceptable, and no relevant issues were found.No photos or physical samples were returned; therefore, return sample analysis could not be performed.This complaint was unable to be confirmed.The root cause could not be identified.A trend analysis for discrepant result was conducted, no adverse trend was identified.No corrective actions were taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

Event Description

It was reported that while using kit grp a strep 30 test veritor they had false positive ¿ all other assays except bactec media bottles the following was rpeorted by the initial reporter: patient 2 of 2 it was reported by the customer that they had discrepant results customer states they have been observing some discrepant results since october 2021, however they never report anything, until this morning in which they observed 1 patient that according to the doctors, had symptoms and they observed two lines in the cartridge but the analyzer gave a negative result, customer wasn't very sure about the results obtained once this test was repeated, first she stated a negative and then a positive result, requesting this info again by email, since she stated that this info needed to be confirmed by the techs that perform the tests.For this patient a culture was requested, and the doctors decided to hold the treatment until culture confirmation.¿ she also spoke about 2 siblings the las week in which one of them had a negative result and the other one a positive result with the veritor analyzer, was confirmed by culture a negative result, and the treatment was stopped.No adverse event reported for this medication change.

• Brand Name: KIT GRP A STREP 30 TEST VERITOR
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17762375
• MDR Text Key: 323582206
• Report Number: 1119779-2023-01006
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: 00382902560401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/17/2023
• Supplement Dates Manufacturer Received: 11/05/2023
• Supplement Dates FDA Received: 12/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other