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

Model Number IST-511

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

Unspecified date: patients presented to the facility for an unspecified reason.Samples were tested on the consult diagnostics strep a kit and a positive result was obtained.Swab for confirmatory culture was collected at the same time as the rapid test and performed same day, however, the results were not available for 48 hours.Physician prescribed antibiotics based on the false positive results obtained on the consult diagnostics strep a kit.Once the culture results were obtained 48 hours later, the facility contacted the patients to advise them to stop taking the antibiotics.No adverse outcomes reported.The culture performed was specific to strep a.Procedural control line was present on all the tests.Although further information was requested, no further information was provided.

Manufacturer Narrative

An investigation was performed on retention and returned product from the reported lot number.Retention and returned devices were tested with asymptomatic clinical samples.Results were read at 5 and 10 minutes, and all devices yielded expected negative results.No false positive 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, as both retention and returned product performed as expected during in-house testing.Please note, 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.

• Brand Name: CONSULT DIAGNOSTICS STREP A DIPSTICK KIT
• Type of Device: STREP A TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 8409174
• MDR Text Key: 142372938
• Report Number: 2027969-2019-00031
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 20612479202720
• UDI-Public: (01)20612479202720(17)200831(10)STA8080076
• Combination Product (y/n): N
• PMA/PMN Number: K010582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: IST-511
• Device Lot Number: STA8080076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1