MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-10-12 for ALERE ORATECT ORATECT XP PM21 manufactured by Ameditech, Inc..
[89259499]
This event occurred in (b)(6) with use of a product indicated for "forensic use only". Ameditech made the decision to report this event to the agency based on the similarity between the product involved in this event and oratect products marketed for in vitro diagnostic use in the united states. The united states marketed products are identifiable by the catalog numbers hm15, aot-06, and x11-aot-06. Device similarities include the detection analytes used to obtain test results, and identical sample collection pads. 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. This event is also the first reported allergic reaction to this device. Given the low allergic potential classification, and low event frequency it was determined that no corrective or preventive actions were required as a result of this event.
Patient Sequence No: 1, Text Type: N, H10
[89259500]
On (b)(6) a test sample for drug screening on an oratect xp device, catalog number pm21, lot number u0827, was collected from a patient. After providing the sample the donor informed the testing technicians that she was allergic to many substances and indicated that her tongue had lost feeling, indicating a possible allergic reaction to the oratect device. The patient was monitored for several minutes and the clinical staff noted that no further symptoms occurred. The patient was then released. The following day the patient consulted a physician, noting that the tongue numbness had not subsided. Her physician contacted the manufacturer local representative requesting a copy of the material safety data sheet for the product. This request was forwarded to ameditech, on september 15. A copy of the material safety data sheet was provided to the local representative and forwarded to the physician on september 17. On (b)(6) the patient had a follow up visit with her physician and presented with a mild rash, irritation to one eye, and indicated that the loss of feeling in her tongue persisted. The physician prescribed a topical skin cream and medicated eye drops to address the patient's symptoms. Three follow-up attempts have occurred since, however no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032598-2017-00001 |
| MDR Report Key | 6945902 |
| Report Source | FOREIGN |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-09-15 |
| Device Manufacturer Date | 2016-12-15 |
| Date Added to Maude | 2017-10-12 |
| 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 | 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 DEIGO 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 | 2017-10-12 |
| Model Number | ORATECT XP |
| Catalog Number | PM21 |
| Lot Number | U0827 |
| Device Expiration Date | 2017-12-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-10-12 |