MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-05-21 for SYVA EMIT CALIBRATOR LEVEL 3 9A569UL manufactured by Syva Co./ Dade Behring, Inc..
[257800]
The patient was admitted to the ed in a comatose condition. The patient was suspected to have overdosed on percocet. The laboratory incorrectly used a 2000 ng/ml cutoff in the qualitative mode for opiate screening vs. The 300 ng/ml cutoff and obtained a negative urine opi (opiate) result. The decision to use the 2000 ng/ml cut-off was made by the laboratory which is contrary to the information provided in the product literature. The negative result was reported. The patient died a few days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2917681-2002-00001 |
| MDR Report Key | 412802 |
| Report Source | 05 |
| Date Received | 2002-05-21 |
| Date of Report | 2002-05-21 |
| Date Mfgr Received | 2002-04-30 |
| Device Manufacturer Date | 2001-04-01 |
| Date Added to Maude | 2002-08-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANITA WAMPLE |
| Manufacturer Street | P.O. BOX 6101 MS 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318102 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYVA EMIT CALIBRATOR LEVEL 3 |
| Generic Name | URINE DRUG OF ABUSE CALIBRATOR |
| Product Code | DKB |
| Date Received | 2002-05-21 |
| Model Number | NA |
| Catalog Number | 9A569UL |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 401857 |
| Manufacturer | SYVA CO./ DADE BEHRING, INC. |
| Manufacturer Address | 20400 MARIANI AVE. CUPERTINO CA 95014 US |
| Baseline Brand Name | SYVA EMIT CALIBRATOR LEVEL 3 |
| Baseline Generic Name | URINE DRUG OF ABUSE CALIBRATOR |
| Baseline Model No | NA |
| Baseline Catalog No | 9A569UL |
| Baseline ID | MS |
| Baseline Device Family | SYVA EMIT CALIBRATOR |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K993755 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2002-05-21 |