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 2018-02-26 for SURESTEP MULTI-DRUG SCREEN TEST UNKNOWN manufactured by Alere San Diego, Inc..
[101171017]
Investigation conclusion: it is indicated that the product is not returning for evaluation. As the customer did not provide a lot number, a manufacturing record review and testing on reserve sample from the same lot could not be performed. Further investigation is not possible at this time. Based on the information available, there is no indication of a product deficiency. A capa, capa (b)(4), has been opened to address the late documentation of this complaint.
Patient Sequence No: 1, Text Type: N, H10
[101171018]
The customer reported receiving negative results for all analytes using a surestep multi-drug screen test with a patient urine sample. All samples at the facility undergo hplc analysis and testing on this sample produced a positive result for benzoylecgonine (cocaine). The customer did not provide a quantitative result but stated the result was above the cut-off value of the screen test. The ph of the urine sample was measured before analysis and resulted in a ph of 14. The customer stated this ph indicated possible modification of the urine. However, there was insufficient sample to repeat the test and the issue could not be replicated by the customer. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00024 |
| MDR Report Key | 7298160 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-26 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2018-02-26 |
| 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 | SURESTEP MULTI-DRUG SCREEN TEST |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2018-02-26 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 2018-02-26 |