MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ACCEAVA STREP A DIPSTICK; STREP A TEST

Model Number	IST-511
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Choking (2464)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported while using the acceava strep a dipstick and swabbing the patient to test for the presence of strep a, the tip of the cotton swab fell off.The customer indicated the detached piece went down the patient's throat causing the patient to choke and expectorate swab tip and is stable.Additionally, the customer reportedly examined three additional cotton swabs from the reported kit, and four cotton swabs each from three additional kits from the same lot and noted the cotton tips from all examined swabs fell off after applying gentle pressure.
Additional Manufacturer Narrative
Results pending completion of the investigation.
Event or Problem Description
The customer reported while using the acceava strep a dipstick and swabbing the patient to test for the presence of strep a, the tip of the cotton swab fell off.The customer indicated the detached piece went down the patient's throat causing the patient to choke and expectorate swab tip and is stable.Additionally, the customer reportedly examined three additional cotton swabs from the reported kit, and four cotton swabs each from three additional kits from the same lot and noted the cotton tips from all examined swabs fell off after applying gentle pressure.
Additional Manufacturer Narrative
F2 - uf/importer report #: previously blank now na.H3 - device evaluated by mfg? previously "no" now "yes".H3 - evaluation summary attached: previously blank now "no".H3 - reason device not evaluated by mfg: now "na" as return testing completed.Investigation conclusion: retained devices and swabs from the reported lot number were visually examined and no damage was observed to the swab or cotton swab tip.The swabs were used to collect sample and negative results were obtained with strong control lines.Returned devices and swabs from the reported lot number were visually examined and no damaged was observed to the swab or cotton swab tips.The returned swabs were then physically examined by applying pressure to the swab and no swab breakage or applicator anomalies were observed.In-house testing did not replicate the reported issue of applicator breakage or cotton swab tips falling off.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.

• Brand Name: ACCEAVA STREP A DIPSTICK
• Common Device Name: STREP A TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 16950792
• Report Number: 2027969-2023-00040
• Device Sequence Number: 11588501
• Product Code: GTY
• UDI-Device Identifier: 10815845020031
• UDI-Public: (01)10815845020031(17)240824(10)0000618571
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K010582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2024
• Device Model Number: IST-511
• Device Catalogue Number: 92001
• Device Lot Number: 0000618571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Male