MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-02-22 for MULTI-DRUG ONE STEP MULTI-LINE 12 DRUG SCREEN TEST DEVICE (URINE) DOA-1125 manufactured by Alere San Diego, Inc..
[137561477]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[137561478]
(b)(6) 2018: (b)(6)-year old female patient was admitted to the emergency department after accidentally ingesting benzodiazepines. A urine sample was tested on the multi-drug one step 12 drug screen test device, and the result was negative. Activated charcoal was administered and monitored. A few hours later, testing on the urine sample was repeated on the multi-drug one step 12 drug screen test device and positive results were obtained for benzodiazepines and cocaine. The customer is not questioning the positive cocaine result as they caught the mother smoking a mixture containing cocaine in the patient's room. Flumazenil was administered, but customer states they do not know whether the treatment was provided before or after the positive bzo result, since the patient had three episodes of desaturation in the first 12 hours. No adverse outcomes reported. Although further information was requested, no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2019-00027 |
| MDR Report Key | 8363939 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-22 |
| Date of Report | 2019-05-23 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-02-22 |
| 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 | MULTI-DRUG ONE STEP MULTI-LINE 12 DRUG SCREEN TEST DEVICE (URINE) |
| Generic Name | DRUG SCREEN |
| Product Code | DIO |
| Date Received | 2019-02-22 |
| Returned To Mfg | 2019-04-30 |
| Model Number | DOA-1125 |
| Lot Number | DOA8090358 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-02-22 |