MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2017-04-20 for MULTIDIP 8 DRUG KIT 25/PK DOA-184 manufactured by Alere San Diego, Inc..
[73386824]
Investigation conclusion: the customer's observation was not replicated in house with retention products. Retention devices were tested with coc and thc +50% cutoff control and 3x cutoff control. All coc and thc results were positive at read time and met qc specifications. No false negative results were observed during in-house testing. Manufacturing batch record review did not uncover any abnormalities. 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
[73386825]
The customer reported a false negative cocaine and thc result on a patient. An oral fluid sample was sent to the laboratory and produced a benzoylecgonine (cocaine) result of 63 ng/ml and a thc result of 7 ng/ml. The appropriate urine sample type was used for the multidip 8 drug test. However, oral fluid is not indicated for this test. Therefore, a direct comparison between the results provided could not be conducted. There was no treatment or intervention administered based on either set of results. No reported adverse patient sequela.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00076 |
| MDR Report Key | 6509463 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2017-04-20 |
| Date of Report | 2017-03-24 |
| Date Mfgr Received | 2017-03-24 |
| Date Added to Maude | 2017-04-20 |
| 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 | MULTIDIP 8 DRUG KIT 25/PK |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2017-04-20 |
| Model Number | DOA-184 |
| Lot Number | DOA6090157 |
| 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 | 2017-04-20 |