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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ACCEAVA STREP A DIPSTICK; STREP A TEST
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ALERE SAN DIEGO, INC. ACCEAVA STREP A DIPSTICK; STREP A TEST Back to Search Results
Model Number IST-511
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2023
Event Type  malfunction  
Event Description
The customer reported while examining the applicator wands from the acceava strep a dipstick kit, gentle pressure was applied and the cotton swab portion of four applicators broke off.Visual examination of the kit boxes noted no physical or cosmetic damage.The customer reported no patient harm or patient involvement.
 
Manufacturer Narrative
Results pending completion of the investigation.H3 other text : although expected, the returned device has not been received for investigation.
 
Manufacturer Narrative
D9 - device available for evaluation changed from "yes" to "no".H2 - if follow-up, what type?: updated to "additional information".H3 - evaluation summary attached update to "no".H3 - additional text: updated to "although requested, returned devices are no longer anticipated." 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.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.H3 other text : although requested, returned devices are no longer anticipated.
 
Event Description
The customer reported while examining the applicator wands from the acceava strep a dipstick kit, gentle pressure was applied and the cotton swab portion of four applicators broke off.Visual examination of the kit boxes noted no physical or cosmetic damage.The customer reported no patient harm or patient involvement.
 
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Brand Name
ACCEAVA STREP A DIPSTICK
Type of Device
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 Key16950750
MDR Text Key315476790
Report Number2027969-2023-00039
Device Sequence Number1
Product Code GTY
UDI-Device Identifier10815845020031
UDI-Public(01)10815845020031(17)240331(10)STA2042019
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Model NumberIST-511
Device Catalogue Number92001
Device Lot NumberSTA2042019
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/19/2023
Initial Date FDA Received05/17/2023
Supplement Dates Manufacturer Received06/13/2023
Supplement Dates FDA Received06/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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