MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for CONSULT STREP A DIPSTICK 4999 50T IST-511 manufactured by Alere San Diego, Inc.
[80247983]
Investigation conclusion: the customer's results were not replicated in-house with retention products of the reported lot. Retention products were tested with positive sample at the qc cutoff (2. 5e07 org/ml). All strips produced positive results at the read time. The product met the qc release specification. False negative results were not observed during the investigation. 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
[80247984]
The customer reported receiving a negative strep a result using the consult strep a dipstick on five patients. For each patient, a culture method provided by (b)(6) produced a positive strep a result. As a result, each patient was delayed in receiving antibiotics for approximately 48 hours before the culture result was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00118 |
| MDR Report Key | 6720403 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-06-19 |
| Date Mfgr Received | 2017-06-19 |
| Date Added to Maude | 2017-07-17 |
| 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 | 0 |
| Brand Name | CONSULT STREP A DIPSTICK 4999 50T |
| Generic Name | STREP A RAPID TEST STRIP |
| Product Code | GTY |
| Date Received | 2017-07-17 |
| Model Number | IST-511 |
| Lot Number | STA6080092 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2017-07-17 |