MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-21 for SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS 474947 manufactured by Beckman Coulter, Inc..
[2360975]
Customer reported to beckman coulter, inc. (bec) that they loaded a new alcohol reagent lot number m104264 onto the unicel dxc 800 synchron system, calibrated it and ran quality control (qc). Customer reported that calibration passed and qc was within specifications. Customer reported that they ran samples and 3 patient samples recovered suppress low. Customer reported that they re ran those 3 patient samples on the other dxc( id (b)(4)) that had alcohol reagent lot number m102182. Customer reported that those three patient samples that were ran using dxc (id (b)(4)) and reagent lot number m102182 recovered low but not suppressed. Customer reported that the erroneous results were not reported outside the laboratory. Customer reported that all the other chemistries were recovering within the lab specification. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9466587]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07830 |
| MDR Report Key | 2344580 |
| Report Source | 05,06 |
| Date Received | 2011-11-21 |
| Date of Report | 2011-10-24 |
| Date of Event | 2011-10-24 |
| Date Mfgr Received | 2011-10-24 |
| Device Manufacturer Date | 2011-04-18 |
| Date Added to Maude | 2011-12-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS |
| Generic Name | ENZYMATIC METHOD, ALCOHOL DEHYDROGENASE, ULTRAVIOLET |
| Product Code | DMT |
| Date Received | 2011-11-21 |
| Catalog Number | 474947 |
| Lot Number | M104264 |
| Device Expiration Date | 2011-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-21 |