MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-11-15 for SURESTEP COCAINE 300 DCO-102 manufactured by Alere San Diego, Inc..
[16685358]
Customer reported potential false negative cocaine result with surestep cocaine 300 on quality controls. Complaint summary: test date: (b)(6) 2013. Matrix: urine charged with benzoylecgonine 0, 5mg/l. Laboratory: the lab yielded a negative result. Testing: performed on 45 controls; results as follows: forty (40) have provided a positive result. Four (4) have provided a negative result. One (1) has provided a suspicious result.
Patient Sequence No: 1, Text Type: D, B5
[16770940]
Investigation: the retain product performed as expected with +50% cutoff control and 3x cutoff control. Manufacturing document review did not observe any failure. The customer's observation was not replicated. The product performed as expected. The issue will be tracked and trended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2013-01038 |
| MDR Report Key | 3663552 |
| Report Source | 01,05 |
| Date Received | 2013-11-15 |
| Date of Report | 2013-10-22 |
| Date of Event | 2013-10-04 |
| Date Mfgr Received | 2013-10-22 |
| Date Added to Maude | 2014-04-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | YA-LING KING, DIRECTOR |
| 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 | SURESTEP COCAINE 300 |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | MVO |
| Date Received | 2013-11-15 |
| Model Number | DCO-102 |
| Lot Number | COC3050013 |
| Device Expiration Date | 2014-12-01 |
| 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 | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-15 |