MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN STREP A DIPSTICK 25T; STREP A TEST

Model Number	IST-511
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	01/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient presented to the facility for pharyngitis and a viral upper respiratory tract infection.Testing was performed on the henry schein strep a kit and a negative result was obtained.Another sample was collected and sent to the lab for confirmatory testing.Confirmatory testing produced a positive result 2 days later.There was a delay in treatment as the patient was then prescribed medication when the confirmatory results were received.Customer stated that there was a negative patient outcome, however, did not provide the outcome.It was also reported that the customer experienced multiple instances of false negative results.Further information regarding the number of instances was requested, but not provided.Troubleshooting was conducted with the customer.Possible causes for unexpected results was discussed, focusing on proper sampling technique and storage conditions per the package insert.The customer was also advised on interpreting the results at the designated read time.
Additional Manufacturer Narrative
Correction: upon following up with the customer to obtain further clarification on the negative patient outcome, the customer stated "after speaking with the doctor there was no negative outcome, she gave patient medication." there was no serious injury to the patient.
Additional Manufacturer Narrative
Retention and returned devices for the reported lot were tested with qc cut-off standard (2.5e07 org/ml).All devices yielded expected positive results at 5 minutes.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformance's, deviations, or abnormalities were found.All quality control specifications were met.Retention products performed as expected during in-house testing and could not replicate the reported complaint.Complaints are tracked and trended on a monthly basis.Per the package insert, excess blood or mucus on the swab specimen may interfere with test performance and may yield a false positive result.Avoid touching the tongue, cheeks, and teeth and any bleeding areas of the mouth with the swab when collecting specimens.As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
Event or Problem Description
Customer stated initially that there was a negative patient outcome, however, did not provide the outcome.Upon following up with the customer on 06/11/2019 to obtain further clarification on the negative patient outcome, the customer stated, "after speaking with the doctor there was no negative outcome, she gave patient medication." there was no serious injury to the patient.
Additional Manufacturer Narrative
Correction: section b1: unmark "adverse event" in the initial mdr as clarification from the customer confirmed no serious injury was reported section b5: additional information provided regarding no negative patient outcome section h1: unmark "malfunction" and "serious injury" on the initial and follow-up #1 and #2 mdr as no malfunction or serious injury was found section h6: change patient code 3191 to 2199.

• Brand Name: HENRY SCHEIN STREP A DIPSTICK 25T
• Common Device Name: STREP A TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8712123
• Report Number: 2027969-2019-00117
• Device Sequence Number: 14065010
• Product Code: GTY
• UDI-Device Identifier: 10304040024147
• UDI-Public: (01)10304040024147(17)200930(10)STA8100003
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/10/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: IST-511
• Device Catalogue Number: 1074050
• Device Lot Number: STA8100003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 06/11/2019; 08/06/2019; 09/09/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/01/2019; 08/07/2019; 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1