MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-10 for REDITEST ON-SITE ORAL FLUID DRUG SCREEN DEVICE DSD-765-011-OBC06 manufactured by Alere San Diego Inc..
[17385985]
Caller alleged that the multi-drug multi-line screen test device "oral swab is falling off of the collectors". Info reported as follows: date: (b)(6) 2013. Quantity: 10. There was no reported adverse pt sequela. There was no additional info provided.
Patient Sequence No: 1, Text Type: D, B5
[17778596]
This device is 510k exempt for forensic use only. Investigation: the devices were not returned for investigation. Evaluation of the retain samples confirmed the customer's complaint. Field action was performed on (b)(6) 2013. Capa ab-13004 has been opened for this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2013-01099 |
| MDR Report Key | 3605509 |
| Report Source | 05 |
| Date Received | 2013-12-10 |
| Date of Report | 2013-05-16 |
| Date of Event | 2013-05-16 |
| Date Mfgr Received | 2013-05-16 |
| Date Added to Maude | 2014-03-25 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2027969-06/03/13-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDITEST ON-SITE ORAL FLUID DRUG SCREEN DEVICE |
| Generic Name | DRUGS OF ABUSE TEST |
| Product Code | MVO |
| Date Received | 2013-12-10 |
| Model Number | DSD-765-011-OBC06 |
| Lot Number | DOA2110317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-12-10 |