MAUDE Adverse Event Report: ALERE SAN DIEGO CONSULT STREP A DIPSTICK 5003 25T; STREP A TEST

Model Number IST-501

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

Results pending completion of investigation.

Event Description

It was reported that on (b)(6) 2019, a patient presented to the facility with symptoms of a sore throat, fever, coughing and a headache.The patient had a strep a kit administered without a timer and a negative result occurred.On (b)(6) 2019 a confirmatory test was performed however no additional information was provided.A negative patient outcome was reported with no other information received although requested.Due to the unknown severity of the negative patient outcome being reported in this case, a conservative approach wil be taken and a serious injury mdr is filed.Per device labeling "limitations" section, "a negative result obtained from this kit should be confirmed by culture.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.As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician." troubleshooting occurred with a discussion about possible causes for unexpected results focusing on proper sampling technique and storage conditions per package insert.

Manufacturer Narrative

This was only one event although uncertain which lot number was associated with the event.The initial filing had lot number sta8120004, but the other potentially involved lot numbers are sta8090042, sta8050042, sta8110032, sta8120010, sta9010014, sta9010055, sta8090043, sta8110027.

Manufacturer Narrative

Investigation conclusion representing lot numbers sta8120004, sta8090042, sta8050042, sta8110032, sta8120010, sta9010014, sta9010055, sta8090043, sta8110027: an investigation was performed on retention and returned products for these reported lot numbers.Retention and returned devices were tested with qc cut-off positive sample (2.5e07org/ml) and results were read at 5 minutes.All devices produced expected positive results at the read time.No false negative results were obtained during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Batch record review found no relevant non-conformances; the lot met all final release specifications.It was reported two drops of reagent a and two drops of reagent b were added into the extraction tube and no color change was observed.The swab was swirled 5-10 times or for 15 seconds and then left in the solution for two minutes.A timer was not used.Per the package insert: add four full drops of reagent 1 (red in color) and four full drops of reagent 2 (colorless) into the extraction tube.The addition of reagent 2 to reagent 1 changes the color of the solution from red to pale yellow.Tap the bottom of the tube gently to mix the liquid.Immediately add the throat swab into the tube of pale yellow solution.Rotate the swab vigorously 10 times in the tube.Leave the swab in the tube for 1 minute.Deviations in testing technique cannot be ruled out as a root cause for the reported issue.A negative result obtained from this kit should be confirmed by culture.

• Brand Name: CONSULT STREP A DIPSTICK 5003 25T
• Type of Device: STREP A TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 8918993
• MDR Text Key: 155194528
• Report Number: 2027969-2019-00240
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 20612479202737
• UDI-Public: (01)20612479202737(17)201130(10)STA8120004
• Combination Product (y/n): N
• PMA/PMN Number: K010582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: IST-501
• Device Lot Number: MULTIPLE LOT NUMBERS-SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Weight: 80