MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-25 for MEDLINE STREP A TEST STRIP IST-501 manufactured by Alere San Diego, Inc.
[115397045]
Investigation conclusion: retention and returned products for the reported lot number were tested with positive samples (2. 5e07 org/ml). Results were read at 5 minutes and all strips showed expected positive results. Manufacturing batch record review did not uncover any abnormalities. Case details indicate swabs included in the kit were not used for sample collection. Swabs from other manufacturers have not been validated for use with this test. This cannot be ruled out as a possible root cause fro the reported issue. 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
[115397046]
The issue was initially reported by the distributor. On (b)(6) 2018, the patient arrived at the facility with congestion and a sore throat that had been occurring for three to four days. The patient also presented with a red throat and white spots on the tonsils. The patient was tested with a medline strep a test strip using a dual swab technique and a negative strep a result was obtained. The customer stated a bactiswab was used for the test instead of the kitted medline strep a test strip swab. The customer stated the swab used was sterile but was unable to confirm if rayon transport swabs containing modified stuart's or amies liquid medium were used. A confirmatory culture was also performed using a bactiswab and later produced a positive strep a result (the date of the strep a culture result could not be provided per the customer). On (b)(6) 2018, the patient was prescribed 500 mg of penicillin vk, 2x/day for 10 days based off the positive culture report. Per the customer, although the patient was delayed in receiving treatment due to the medline strep a test strip result, no adverse patient outcome occurred. Troubleshooting was conducted with the customer. The customer was advised to use validated swabs (rayon transport swabs containing modified stuart's or amies liquid medium). Furthermore it was recommended that a single swab method be employed when using a medline strep a test strip test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00096 |
| MDR Report Key | 7720705 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-25 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-05-15 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-07-25 |
| 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 | MEDLINE STREP A TEST STRIP |
| Generic Name | STREP A RAPID TEST STRIP |
| Product Code | GTY |
| Date Received | 2018-07-25 |
| Returned To Mfg | 2018-07-09 |
| Model Number | IST-501 |
| Lot Number | STA8010024 |
| Device Expiration Date | 2019-12-31 |
| 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 | 2018-07-25 |