MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-15 for LACTATE REAGENTS 10325776 manufactured by Siemens Healthcare Diagnostics, Inc..
[40671090]
Siemens healthcare diagnostics has become aware of n- acetylcysteine (nac) and metamizole (dipyrone) interference with trinder and trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving n- acetylcysteine (nac) or metamizole. The instructions for use (ifu) for the advia chemistry assays cholesterol_2, cholesterol_c, enzymatic creatinine_2, glucose oxidase, triglycerides_2, tricglycerides_2 concentrated, uric acid, uric acid, concentrated reagents, and fructosamine, (in the limitations of the procedure section) will be updated to indicate that: venipuncture should occur prior to n-acetyl cysteine (nac) or metamizole administration due to the potential for falsely depressed results. The instructions for use (ifu) for the advia chemistry assays ldl cholesterol direct and direct hdl cholesterol, (in the limitations of the procedure section) will be updated to indicate that: venipuncture should occur prior to metamizole administration due to the potential for falsely depressed results. The instructions for use (ifu) for the advia chemistry assays lactate, glucose oxidase concentrated reagents (in the limitations of the procedure section) will be updated to indicate that: venipuncture should occur prior to n-acetyl cysteine (nac) administration due to the potential for falsely depressed results. An urgent field safety notice (ufsn) chc16-01. A. Ous was sent to ous customers and a urgent medical device correction (umdc) chc16-01. A. Us was sent to us customers in march of 2016. The ufsn and umdr will notify customers that venipuncture should occur before drug administration of nac or metamizole, due to the potential for depressed results as indicated above for each assay.
Patient Sequence No: 1, Text Type: N, H10
[40671091]
The customer would like information on specific interferants like n-acetylcysteine (nac) and metamizole in reagents that use the trinder reaction on the advia chemistry instruments. The customer had received a letter from another manufacturer indicating possible interferences with n-acetylcysteine (nac) and metamizole and potential impact on assays that use the trinder reaction. The trinder reaction is a reaction where hydrogen peroxide is formed and subsequently reacts with a phenol derivative and aminoantipyrine in the presence of peroxidase to form a colored quinone product. Nac is the accepted antidote for acetaminophen toxicity and is justified in patients at significant risk for hepatotoxicity. Metamizole is an anti-inflammatory anti-pyretic drug banned in most countries because of the potential for nephrotoxicity. It is unknown if any patient results were reported to the physician(s). There were no reports of patient intervention or adverse health consequences.
Patient Sequence No: 1, Text Type: D, B5
[45263781]
The initial mdr 2432235-2016-00131 was filed on 3/15/2016. Additional information (3/22/2016): please note additional information in report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00131 |
| MDR Report Key | 5502648 |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-14 |
| Date of Event | 2015-07-17 |
| Date Mfgr Received | 2016-03-22 |
| Date Added to Maude | 2016-03-15 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | RANDOX LABORATORIES LTD. (REG# 8020890) |
| Manufacturer Street | 55 DIAMON ROAD CRUMLIN |
| Manufacturer City | CO. ANTRIM, BT294QY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BT29 4QY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-03/22/2016-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LACTATE REAGENTS |
| Generic Name | LACTATE REAGENTS |
| Product Code | CFJ |
| Date Received | 2016-03-15 |
| Model Number | LACTATE REAGENTS |
| Catalog Number | 10325776 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-15 |