MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-08-28 for TOTAL PROTEIN URINE/CSF GEN.3 03333825190 manufactured by Roche Diagnostics.
[25124672]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[25124673]
The customer reported that they were getting complaints of low recovery for an unspecified number of patient cerebrospinal fluid samples tested for total protein urine/csf gen. 3 (tpuc) on an integra 400 plus analyzer. The results from the integra 400 plus analyzer were not correlating with the clinical symptoms of the patients. Recoveries were found to be higher when the samples were checked on other systems. The customer site is a "neuro" hospital. The customer provided data for five patient samples that had questionable results when tested for tpuc on the integra 400 plus as compared to either the au2700 system or the siemens dimension analyzer. Of the data provided, 2 patients had erroneous results which were reported outside of the laboratory. The customer then provided data for 3 additional patient samples which had erroneous tpuc results. Of the three samples, two had erroneous results that were reported outside of the laboratory. These samples were repeated on a siemens dimension analyzer, which uses the pyrogallol red method. The first sample initially resulted as 58 mg/dl on the integra 400 plus analyzer and reported outside of the laboratory to a physician. The physician sent the sample to another laboratory for a cross check on a siemens analyzer. The result from the siemens analyzer was 90 mg/dl and the physician noted that this result correlated to the patient's clinical condition. The second sample, from a(b)(6) old male, initially resulted as 42 mg/dl when tested on the integra 400 plus. The initial result was reported outside of the laboratory. The sample was tested on a siemens analyzer where it resulted as 148 mg/dl. It was stated that patient treatment was delayed for a few days while waiting for data from the siemens instrument. It was also stated that patient treatment was initiated while taking the siemens results into consideration. No adverse events were alleged for these patients. The integra 400 plus analyzer serial number was (b)(4). Per customer request, the integra 400 plus was adjusted with an instrument factor. A specific root cause could not be determined. There was no evidence the roche results were incorrect. The most likely explanation for the observed difference in results is that each analyzer method uses different reference standardization. Additional information for further investigation was requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2015-04043 |
| MDR Report Key | 5039191 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-08-28 |
| Date of Report | 2015-08-28 |
| Date of Event | 2015-05-16 |
| Date Mfgr Received | 2015-05-18 |
| Date Added to Maude | 2015-08-28 |
| 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 | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| 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 | TOTAL PROTEIN URINE/CSF GEN.3 |
| Generic Name | TURBIDIMETRIC, TOTAL PROTEIN |
| Product Code | JGQ |
| Date Received | 2015-08-28 |
| Model Number | NA |
| Catalog Number | 03333825190 |
| Lot Number | 60095101 |
| ID Number | NA |
| Device Expiration Date | 2015-09-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-08-28 |