MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-01-12 for MICROGENICS 0911 manufactured by Microgenics, Thermo Fisher Scientific, Diagnostics Div.
[941165]
Customer reported that the assay pt result, using the advia 2400 instrument, was negative at 2. 8 ug/ml, below the cut-off calibrator or 3. 0 ug/ml, by the dri serum tox barbiturate assay. However, the confirmation of the result was 28 ug/ml of pentobarbital by gc/ms (gas chromatography/mass spectrometry). Confirmation by gc/ms is the gold standard of testing for this type of assay. The customer used the 3. 0 ug/ml cut-off calibrator instead of the recommended cut-off by microgenics packaging insert of 1. 0 ug/ml; inappropriate use of the prod. Customer stated that the package insert states that the result would be positive for pentobarbital at a concentration of 5 ug/ml (which is correct only for the cut-off at 1. 0 ug/ml). Pt is known to take barbiturates and it is a neonate sample.
Patient Sequence No: 1, Text Type: D, B5
[8095938]
This form has been completed at the behest of fda that it accompany our reply to its request for add'l info. Prod was used inappropriately according to the directions of the package insert - there was no device failure and no mdr-reportable event occurred. A copy of fda's 14-nov-2006 request for add'l info and a response to it are enclosed. Thermofisher (formerly microgenics) has determined that the event is not attributable to the device. Customer has insufficient amount of the original sample to send for microgenics in-house testing. Customer sent a new sample from same pt. Customer stated that this new sample tested negative by the dri serum tox assay, but their reference lab reported, it was 6. 0 um/ml. Microgenics tested in house on hitachi 717 instrument and the result was negative, below the cut-off calibrator of 1. 0 ug/ml. Gc/ms testing of the prod sample was repeated by microgenics to be 5. 7 ug/ml. Customer decided to stop using assay as they believe it is not performing to package insert spec. Dr stated she is also in the process of sending in a mda to the fda. Customer stated that they used the assay to monitor the level of pentobarbital. Pentobarbital is being given to pts in a coma to keep brain swelling down. Pentobarbital level has to be below a certain level before organs can be harvested. Microgenics explained that the level of 5 ug/ml pentobarbital listed in the package insert is based on the cut-off level of 1 ug/ml and at higher concentrations the x-reactivity would be different. In addition, the assay is not intended for pentobarbital monitoring. Customer has decided to use 3 ug/ml as cut-off since it is the level to distinguish toxic samples. Microgenics informed customer that the higher cut-off would change the assay profile and the sensitivity of the other barbiturates from the levels listed in the package insert. Those levels are indicated for the 1. 0 ug/ml cut-off. Customer states that the lab has stopped using this assay and that dr will call back if she has more info. Dri serum box barbiturate assay is a class assay that detects different barbiturates at different sensitivities. The assay is not intended for monitoring a particular barbiturate analyte. The assay utilizes a calibrator spiked with on of the barbiturates at a recommended concentration of 1 ug/ml. By the customer changing the cutoff calibrator to a higher level from 1 to 3 ug/ml (not recommended by the prod package insert), the assay sensitivity level increased as well. Remedial action: customer was informed that they are using the assay incorrectly. It is an inappropriate use of this test for monitoring. According to the directions of the package insert - use for serum toxicology assay only in the er situations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937369-2006-00001 |
| MDR Report Key | 1160883 |
| Report Source | 06 |
| Date Received | 2007-01-12 |
| Date of Report | 2007-01-09 |
| Date of Event | 2006-07-17 |
| Date Mfgr Received | 2006-07-18 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2008-09-17 |
| 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 | 0 |
| Manufacturer Street | 46360 FREMONT BLVD |
| Manufacturer City | FREMONT CA 94038 |
| Manufacturer Country | US |
| Manufacturer Postal | 94038 |
| Manufacturer Phone | 5107975000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROGENICS |
| Generic Name | DRI BARBITURATE SERUM TOX ASSAY |
| Product Code | DIS |
| Date Received | 2007-01-12 |
| Model Number | NA |
| Catalog Number | 0911 |
| Lot Number | 56561925 |
| ID Number | NA |
| Device Expiration Date | 2008-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1181178 |
| Manufacturer | MICROGENICS, THERMO FISHER SCIENTIFIC, DIAGNOSTICS DIV |
| Manufacturer Address | 46360 FREMONT BLVD FREMONT CA 94038 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-12 |