MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. STREP A RAPID TEST STRIP (THROAT SWAB); STREP A TEST

Model Number IST-501

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: an investigation was performed on retention devices from the reported lot number.Retention devices were tested with qc positive standards (2.5e7 org/ml).Results were read at 5 minutes and all devices yielded expected positive results.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and found that the lot met quality control specifications.A root cause could not be determined from the available information.A negative result may be obtained if the concentration of the strep a antigen present in the throat swab is not adequate or is below the detectable level of the test.Therefore, it is recommended that a negative result obtained from this kit be confirmed by culture.

Event Description

Unconfirmed false negative result on the strep a rapid test strip.Patient's condition worsened as a result of the false negative result obtained and patient was hospitalized with complications.Unknown if confirmatory testing was performed.Although further information was requested, no further information was able to be obtained from the complainant.

• Brand Name: STREP A RAPID TEST STRIP (THROAT SWAB)
• Type of Device: STREP A TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052804
• MDR Report Key: 8149379
• MDR Text Key: 129889923
• Report Number: 2027969-2018-00166
• Device Sequence Number: 1
• Product Code: GTY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: IST-501
• Device Lot Number: STA7100023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization