MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-30 for RD SAMPLE CUP MICRO 13/16 05085713001 manufactured by Roche Diagnostics.
[16730505]
The customer reported that they received an erroneous result for one patient sample tested for total bilirubin special (tbil). The customer stated that they started noticing issues with erroneous sample results when they switched to the new version of the micro cup (rd sample cup micro 13/16). The customer was not able to provide any data for previous occurrences of erroneous results. The sample initially resulted as 0. 3 mg/dl and this value was reported outside of the laboratory. A "tech" questioned the result and repeated the sample, resulting as 13. 0 mg/dl. The repeat value of 13. 0 mg/dl was believed to be correct. The patient was not adversely affected by the event. The tbil reagent lot number was 65988801 with an expiration date of 07/31/2013. All testing was performed on c501 analyzer serial number (b)(4). The customer refused a service visit.
Patient Sequence No: 1, Text Type: D, B5
[17043608]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[20904497]
A specific root cause could not be determined. A handling error is the most likely cause. No adverse event was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-02893 |
| MDR Report Key | 2592544 |
| Report Source | 05,06 |
| Date Received | 2012-05-30 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-05-14 |
| Date Mfgr Received | 2012-05-15 |
| Date Added to Maude | 2012-05-30 |
| 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 | 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 INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RD SAMPLE CUP MICRO 13/16 |
| Generic Name | CONTAINER, SPECIMEN, NON-STERILE |
| Product Code | NNI |
| Date Received | 2012-05-30 |
| Model Number | NA |
| Catalog Number | 05085713001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-05-30 |