MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-10-02 for ALERE ORATECT ORATECT III HM12-CE manufactured by Ameditech, Inc..
[122451465]
This event occurred in (b)(6) with a product of identical manufacturing to a us marketed product. Ameditech made the decision to report this event to the agency based on the similarity between the product involved in this event and the oratect iii, catalog numebr hm12, product marketed for in vitro diagnostic use in the united states. Device similarities include the detection analytes used to obtain test results, and identical sample collection pads, with the major diference being the ce marked labeling for the devices sold in (b)(6). The sample collection pad is the point of contact between the device and the patient, and is the likely component to which the patient may have experienced allergic symptoms. Kligman maximization testing was performed on this collection pad in 2014. This testing categorized the collection pad with a grade 1 sensitization rate, the lowest available allergic potential score. Thus the risk of allergic reaction has been reduced as far as possible. A historical review was conducted and determined that this is the first allergic reaction reported for the catalog number, and the second report for the oratect product family since distribution of the product began in 2012, thereby indicating a low frequency of occurrence. Further investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[122451466]
On (b)(6) 2018 a test sample for drug screening on an oratect iii device, catalog number hm12-ce was collected from a patient. After providing the sample the donor informed the testing technician that he was experiencing some irritation and blistering on the inside of his cheek, indicating a possible allergic reaction to the oratect device. The patient was monitored for several minutes and the testing staff noted that no further symptoms occurred. The patient was then released, and did not seek further medical attention. Repeated attempts to gather lot number information from the customer were made on (b)(6), 11th, 12th, 13th, 19th, 20th, and 24th, however the customer was unable to confirm the lot of product involved in the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032598-2018-00001 |
| MDR Report Key | 7928072 |
| Report Source | FOREIGN |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-09-07 |
| Date Mfgr Received | 2018-09-07 |
| Date Added to Maude | 2018-10-02 |
| 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 | MS. ANGELA OCCHIONERO |
| Manufacturer Street | 9940 MESA RIM ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8585351968 |
| Manufacturer G1 | AMEDITECH, INC. |
| Manufacturer Street | 9940 MESA RIM ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE ORATECT |
| Generic Name | ORATECT ORAL FLUID DRUG SCREEN DEVICE |
| Product Code | DJC |
| Date Received | 2018-10-02 |
| Model Number | ORATECT III |
| Catalog Number | HM12-CE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMEDITECH, INC. |
| Manufacturer Address | 9940 MESA RIM ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-02 |