MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-19 for RD SAMPLE CUP MICRO 13/16 05085713001 manufactured by Roche Diagnostics.
[2499171]
The customer alleged questionable glucose hk gen 3 (glucose) results on one csf specimen. All testing was performed on (b)(4) module (b)(4). The initial glucose result was 0 mg/dl with a data flag. The analyzer automatically repeated the test with an increased sample volume. The result was again 0 mg/dl with a data flag; this result was reported outside the laboratory. The doctor requested the sample be repeated. It was repeated twice on the same analyzer with results of 57 mg/dl and 58 mg/dl. A corrected report was generated with the 58 mg/dl result. The customer stated there was no adverse event. The glucose reagent lot number was 64655001, with an expiration date of 09/30/2012. The customer stated the microcups used when testing the sample have an edge on the side which impedes them from seeing if the sample has bubbles in it. The customer declined a service visit since they felt the problem was due to bubbles in the sample.
Patient Sequence No: 1, Text Type: D, B5
[9574666]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[9865717]
It was unknown if the initial reporter sent report to the fda. The investigation determined that, due to "ridges" on the cups, customers may find it more difficult to check the sample level and presence of foam on the sample material. Labeling for the (b)(4) module instructs the user to make sure that the samples contain no contaminants such as fibrin, dust, or bubbles when loading samples onto the analyzer.
Patient Sequence No: 1, Text Type: N, H10
[18524264]
It was unknown if the initial reporter sent report to the fda. The investigation determined that, due to "ridges" on the cups, customers may find it more difficult to check the sample level and presence of foam on the sample material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-06795 |
| MDR Report Key | 2381257 |
| Report Source | 05,06 |
| Date Received | 2011-12-19 |
| Date of Report | 2012-05-14 |
| Date of Event | 2011-12-08 |
| Date Mfgr Received | 2011-12-08 |
| Date Added to Maude | 2011-12-19 |
| 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 | 2011-12-19 |
| Model Number | NA |
| Catalog Number | 05085713001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-12-19 |