MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-02 for ONLINE DAT BENZODIAZEPINES PLUS 04499034190 manufactured by Roche Diagnostics.
[19387581]
The customer provided the involved patient sample for investigation. It was determined that the sample was negative with the complained benzodiazepines reagent. For gc-ms measurement, an enzymatic glucuronidase cleavage is typically performed, so the measurement would be a sum of oxazepam, lorazepam and its glucuronides. The benzodiazepines assay that the customer used has very low cross reactivity for glucuronides (oxazepam glucuronide is not cited in the package insert, but the structure is similar to lorazepam glucuronide and the cross reactivity for this is claimed at approximately (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[20791415]
The customer reported that they received erroneous results for one patient urine sample tested for benzodiazepines plus (benzodiazepines). The customer uses a semiquantitative application of the assay with a 200 ng/ml cutoff. The sample initially recovered a value of 143 ng/ml which is considered negative. The result was reported outside of the laboratory. The customer received a complaint from their client, so the sample was repeated. The sample was sent to a reference laboratory for confirmation where it was tested using gc/ms on (b)(6) 2012. The gc/ms result was negative for nordiazepam (100 ng/ml cutoff), 140 ng/ml for oxazepam (100 ng/ml cutoff), negative for temazepam (100 ng/ml cutoff), 640 ng/ml for lorazepam (100 ng/ml cutoff), negative for flurazepam metabolite (100 ng/ml cutoff), and negative for alprazolam (50 ng/ml cutoff for alpha- hydroxyalprazolam). The sample was aliquoted and both the aliquot and original sample were repeated using the same p module analyzer on (b)(6) 2012. The repeat of the aliquot resulted as 111 ng/ml and the repeat of the original sample resulted as 130 ng/ml. The sample aliquot and original sample were also repeated a second time using a different p module analyzer (serial number (b)(4)) on (b)(6) 2012. The second repeat of the aliquot on p module serial number (b)(4) resulted as 119 ng/ml and the second repeat of the original sample on p module serial number (b)(4) resulted as 126 ng/ml. The customer believed the gc/ms confirmation results to be the correct results. The patient was not adversely affected by the event. The benzodiazepines reagent lot number was 64948901 with an expiration date of 06/30/2013. The field service representative was not able to determine a cause. He performed checks on the module for rinsing of the cells, the probes and stirrers. He checked the vacuum pressures and water pressures. He checked the probe alignments and lubricated the probe shafts. He recalibrated the assay with passing results. He also ran quality controls and the results were at or near the customer's mean. He ran precision testing and the results were within guidelines.
Patient Sequence No: 1, Text Type: D, B5
[20906987]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-04920 |
| MDR Report Key | 2769641 |
| Report Source | 05,06 |
| Date Received | 2012-10-02 |
| Date of Report | 2012-11-13 |
| Date of Event | 2012-09-18 |
| Date Mfgr Received | 2012-09-26 |
| Date Added to Maude | 2012-10-02 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONLINE DAT BENZODIAZEPINES PLUS |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZIPINE |
| Product Code | JXM |
| Date Received | 2012-10-02 |
| Model Number | NA |
| Catalog Number | 04499034190 |
| Lot Number | 64948901 |
| ID Number | NA |
| Device Expiration Date | 2013-06-30 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-02 |