MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-06-29 for CONSULT STREP A DIPSTICK 5003 25T IST-501 manufactured by Alere San Diego, Inc.
[112900550]
Investigation conclusion: retention and returned products for the reported lot number were tested with asymptomatic clinical samples. Results were read at 5 minutes and at 10 minutes. All strips correctly yielded negative results. No false positive result were observed. Manufacturing batch record review did not uncover any abnormalities. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[112900551]
On (b)(6) 2018, a (b)(6) patient arrived at the facility with a sore throat. The patient was tested with a consult strep a dipstick test using a dual swab method and a positive strep a result was received. The patient was prescribed amoxicillin 400 mg based on the consult strep a dipstick test and sent home. A culture was performed and was grown on disks specific for group a strep a over a period of 48 hours. On (b)(6) 2018, the customer received the results of the culture. The culture was negative for strep a. The customer contacted the patient/guardian the same day and advised discontinuation of the amoxicillin 400 mg course previously prescribed. The customer was unable to confirm how many days the patient took the medication but stated it could not have been more than two days. The patient was prescribed symptomatic treatment for the sore throat and upon follow-up the patient was reported as "doing fine. " the final diagnosis of the patient was pharyngitis. Troubleshooting was performed with the customer. The customer was advised that saliva and mucous may contribute to the false positive result and that this kit is only validated for use with a single swab technique.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00078 |
| MDR Report Key | 7651497 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-05-14 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2018-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONSULT STREP A DIPSTICK 5003 25T |
| Generic Name | STREP A RAPID TEST STRIP |
| Product Code | GTY |
| Date Received | 2018-06-29 |
| Returned To Mfg | 2018-06-21 |
| Model Number | IST-501 |
| Lot Number | STA7120056 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |