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 2017-04-14 for TOBR2 TOBRAMYCIN 04491033190 manufactured by Roche Diagnostics.
[72887977]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[72887978]
The customer has tested 1 patient with tobr2 tobramycin (tobr2) on a cobas 6000 series system, tobr tobramycin (tobr) on a cobas integra system and the abbott tobramycin assay on an architect system. The customer provided results from the patient obtained between (b)(6) 2015 and (b)(6) 2017. The customer is questioning the tobr2 results from the cobas 6000 series system because they are consistently higher even after stopping tobramycin treatment and without the patient showing any symptoms of toxicity. The customer thinks the tobr results from the integra system are correct. Based on the data provided, comparison results on (b)(6) 2015 between the tobr2 assay on the cobas 6000 system and the tobr assay on the cobas integra system were erroneous. Refer to attached data for a chronological list of the patient test results, specific treatment received and patient weight at time of test if available. There was no allegation that an adverse event occurred. The customer believes there is an interferent in the patient sample affecting the results. The customer performed a series of investigations in an attempt to identify the interference. Refer to the attached data for the details of the customer? S investigation. All the samples from the patient were taken at trough level. Some patient results were from finger stick tests and some patient results were from venous samples. It is not clear which results are from venous samples and which results are from finger sticks. Peak level samples are not monitored by the customer. The customer declines to provide calibration or quality control (qc) data as they don? T believe this is a method quality issue. A specific root cause could not be identified. Additional information was requested for investigation but was not provided. Two assays, the tobr2 with c6000 system and the tobramycin assay with the architect system are competitive immunoassay methods; one utilizing a polyclonal, and the other a monoclonal capture antibody, respectively. Only the competitive tobr assay with the integra system employing a monoclonal ab, seemed to produce the negative results expected for this patient. Since qc has been acceptable, analytical and pre-analytical quality issues have been excluded. The investigation stated an unknown substance is interfering with the tobr2 assay, however, since the patient sample is not available, this cannot be confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00787 |
| MDR Report Key | 6494067 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-14 |
| Date of Event | 2015-12-02 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2017-04-14 |
| 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 | TOBR2 TOBRAMYCIN |
| Generic Name | TOBRAMYCIN TEST SYSTEM |
| Product Code | KLB |
| Date Received | 2017-04-14 |
| Model Number | NA |
| Catalog Number | 04491033190 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-14 |