MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-11 for CONSULT DIAGNOSTICS STREP A DIPSTICK KIT IST-511 manufactured by Alere San Diego, Inc..
[142372938]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[142372939]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2019-00031 |
| MDR Report Key | 8409174 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-11 |
| Date of Report | 2019-04-04 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-03-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 RD |
| 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 DIAGNOSTICS STREP A DIPSTICK KIT |
| Generic Name | STREP A TEST |
| Product Code | GTY |
| Date Received | 2019-03-11 |
| Returned To Mfg | 2019-03-05 |
| Model Number | IST-511 |
| Lot Number | STA8080076 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-11 |