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 2017-11-29 for CONSULT STREP A DIPSTICK 4999 50T IST-511 manufactured by Alere San Diego, Inc.
[93293682]
Investigation conclusion: the corresponding package insert and the msds states to wear protective clothing, disposable gloves and eye protection when using the product. The customer failed to adhere to the instructions included in the labeling. Additionally, the package insert include the following warnings: warning: reagent 1 is harmful if swallowed or absorbed through skin. May cause eye irritation; caution: reagent 2 may cause skin, eye and respiratory tract irritation. Reagent a contains sodium nitrite and reagent b contains acetic acid. If the skin comes in contact with these reagents, the affected area should be thoroughly washed with water. There is no significant immediate health risk to operator/user provided the user should be well protected in accordance with the package insert as msds. 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
[93293683]
The customer reported that a few drops of reagent 1 and 2 solution from consult strep a dipstick test splashed out of the extraction tube and onto her hand. The customer was not wearing disposable gloves as instructed in the package insert. The customer immediately flushed the affected area with a large amount of water. Although no subsequent injury was reported, this event is being conservatively filed as the solution may be harmful if absorbed through the skin per corresponding labeling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00175 |
| MDR Report Key | 7069311 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-11-29 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-10-31 |
| Date Mfgr Received | 2017-10-31 |
| Date Added to Maude | 2017-11-29 |
| 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 4999 50T |
| Generic Name | STREP A RAPID TEST STRIP |
| Product Code | GTY |
| Date Received | 2017-11-29 |
| Model Number | IST-511 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-11-29 |