MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for LACTATE REAGENT (LACT 2 X 50) A95550 manufactured by Beckman Coulter.
[45225829]
Beckman coulter studies determined that metamizole (dipyrone) interferes with beckman coulter synchron lactate assay: interference seen with 0. 8 mg/ml dipyrone (max daily dose) was a negative bias of 19. 9%. Interference seen with 4 mg/ml dipyrone (5x daily dose) was a negative bias of 41. 6%. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45225830]
Metamizole (dipyrone) has been identified as an undocumented interferent which may cause false low lactate (lact) results. No external customer complaints have been received for this particular issue. No results were reported outside the laboratory. There was no report of change in patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050010-2016-00002 |
| MDR Report Key | 5648413 |
| Date Received | 2016-05-11 |
| Date of Report | 2016-04-21 |
| Date of Event | 2016-04-21 |
| Date Mfgr Received | 2016-04-21 |
| Date Added to Maude | 2016-05-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD M/S E1.SE.01 |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2470 FARADAY AVE |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LACTATE REAGENT (LACT 2 X 50) |
| Generic Name | NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE |
| Product Code | CFJ |
| Date Received | 2016-05-11 |
| Model Number | LACTATE |
| Catalog Number | A95550 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-11 |