MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-17 for SYNCHRON? SYSTEMS BENZODIAZEPINES (BNZG) REAGENT A18298 manufactured by Beckman Coulter, Inc..
[2202479]
The customer reported that erroneously positive benzodiazepine (bnzg) results were generated from a unicel dxc 600i synchron access clinical system for an unknown number of patient samples for a specific synchron systems benzodiazepines (bnzg) reagent lot. Instrument bnzg quality controls results recovered as positive for negative qc control materials during the timeframe of this event. No erroneous bnzg results were reported outside of the laboratory hence there was no death, serious injury or modification to patient treatment associated or attributed to this event. Initial results were repeated at a third party laboratory. The repeat results were different from the initial results, and were considered valid. The customer changed synchron systems benzodiazepines (bnzg) reagent lots, and quality control results responded by returning back into established specification range. Data provided by the customer indicates the generation of an initial positive bnzg result, which upon repeat on another instrument generated a negative repeat result. The samples were urine patient samples.
Patient Sequence No: 1, Text Type: D, B5
[9401722]
Event appears to be reagent related. Service was not dispatched to the site for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-03776 |
| MDR Report Key | 2213762 |
| Report Source | 05,06 |
| Date Received | 2011-08-17 |
| Date of Report | 2011-07-08 |
| Date of Event | 2011-07-07 |
| Date Mfgr Received | 2011-07-08 |
| Device Manufacturer Date | 2011-04-18 |
| Date Added to Maude | 2012-05-09 |
| 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 | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? SYSTEMS BENZODIAZEPINES (BNZG) REAGENT |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZIPINE |
| Product Code | JXM |
| Date Received | 2011-08-17 |
| Model Number | NA |
| Catalog Number | A18298 |
| Lot Number | M104042 |
| ID Number | NA |
| Device Expiration Date | 2012-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-17 |