MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-21 for REDITEST ON-SITE ORAL FLUID DRUG SCREEN DEVICE DSD-765-011-OBC06 manufactured by Alere San Diego, Inc.
[16687054]
Caller alleged that the multi-drug multi-line screen test device sponge dislodged from the collector handle while collecting oral fluid specimens. This device is for forensic use only. Info reported as follows: date: (b)(6) 2013; case number: (b)(4); lot number doa2110317/b21003; quantity: 7. On (b)(6) 2013; (b)(4); doa2110317/b21003; 30. On (b)(6) 2013; (b)(4); doa2110317/b21003; 25. On (b)(6) 2013; 00456614; doa2110317/b21003; 5 and on (b)(6) 2013; (b)(4); doa2110317/b21003; 85. The following case was reported under a separate medwatch form. Date: (b)(6) 2013; case number: (b)(4); lot number doa2110316/b21003/b121001; quantity: 15. There were no reported adverse pt sequela. There were no add'l info provided.
Patient Sequence No: 1, Text Type: D, B5
[16843193]
This device is 510k exempt for forensic use only. Investigation: the lot number, product number and product description were verified. The devices were not returned for investigation. Evaluation of the retain samples confirmed the customer's complaint. A review of all lots within a 2 year shelf-life was conducted. Capa (b)(4) was opened for this issue. The following case was reported under a separate medwatch from. Case number: (b)(4); lot number: doa2110316/b121003/b12001; medwatch form: 2027969-2013-00497.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2013-00496 |
| MDR Report Key | 3196026 |
| Report Source | 05 |
| Date Received | 2013-06-21 |
| Date of Report | 2013-06-20 |
| Date of Event | 2013-04-04 |
| Date Mfgr Received | 2013-06-03 |
| Date Added to Maude | 2013-09-16 |
| 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 | CARMEN BERGELIN, REG COMPL MGR |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| 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 | 2013-06-21 |
| Model Number | DSD-765-011-OBC06 |
| Lot Number | DOA2110317/B21003 |
| 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 | 2013-06-21 |