MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-05 for ANALYTICAL P MODULE 03738965001 manufactured by Roche Diagnostics.
[3953198]
The customer received false positive benzodiazepine results from two analytical p module analyzers for one urine sample. The initial result from analytical p module serial number (b)(4) was 437 ng/ml and was reported outside the laboratory. On (b)(6) 2013 the confirmatory test performed by (b)(6) was received and the result was negative. The sample was repeated on analytical p module serial number (b)(4) and the results were 433 ng/ml from an aliquot and 413 ng/ml from the original container. The repeat result by gc-ms was believed to be the correct result. The patient was not adversely affected. The benzodiazepine reagent lot number was 68217001 with an expiration date of 01/31/2015. The field service representative could not determine a cause. He checked the vacuum and gear pump pressures, changed the gear pump head, checked the rinse mechanism with no problems and verified the rinse volumes were within specifications. He noted the reagent probes were last changed one year ago so he changed the r1 & r2 probes, lubricated the sample and reagent mechanisms and checked the probe alignments and rinsing of the probes. To verify the analyzer operation, he ran precision testing with results within guidelines.
Patient Sequence No: 1, Text Type: D, B5
[11133428]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11450146]
The investigation could not determine a specific root cause as the sample was not available for further testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-05470 |
| MDR Report Key | 3327197 |
| Report Source | 05,06 |
| Date Received | 2013-09-05 |
| Date of Report | 2013-10-23 |
| Date of Event | 2013-08-15 |
| Date Mfgr Received | 2013-08-22 |
| Date Added to Maude | 2013-09-05 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANALYTICAL P MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NFV |
| Date Received | 2013-09-05 |
| Model Number | NA |
| Catalog Number | 03738965001 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 2013-09-05 |