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 2017-11-30 for GLUC3 GLUCOSE HK GEN.3 04404483190 manufactured by Roche Diagnostics.
[94216145]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[94216147]
The customer complained of erroneous results for 1 patient tested for gluc3 glucose hk (gluc3) on 2 cobas 6000 c (501) modules used in the biochemistry laboratory of the hospital. Two sample tubes were drawn at the same time and tested on both of the customer? S c501 modules with results of either <0. 020 g/l and 0. 03 g/l or with results of 0. 04 g/l. Clarification on the correct results has been requested but has not been provided. Both sample tubes were also tested on the customer? S abl825 blood gas system after a 1:10 dilution and both results were 0. 03 g/l. It is not clear if the erroneous results were reported outside of the laboratory. Another sample tube that was drawn at the same time was tested immediately in the intensive care unit of the hospital and the result from that blood gas system was 1. 23 g/l. No adverse event occurred. The customer indicated the low gluc3 results were not believable. The c501 module serial numbers were not provided. The customer is wondering if something inside the patient sample would have destroyed the glucose in vitro more quickly than normal causing the lower results. An interference with the gluc3 assay is unlikely since the test principles between a c501 module and the blood gas system are very different. Since the determination of glucose must be carried out immediately after drawing blood, the decrease of glucose concentration must have occurred rapidly. Typically, the intensive care unit staff uses a capillary blood sample and runs the glucose test immediately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02792 |
| MDR Report Key | 7071328 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-30 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2017-11-10 |
| Date Added to Maude | 2017-11-30 |
| 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 | 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 | GLUC3 GLUCOSE HK GEN.3 |
| Generic Name | HEXOKINASE, GLUCOSE |
| Product Code | CFR |
| Date Received | 2017-11-30 |
| Model Number | NA |
| Catalog Number | 04404483190 |
| Lot Number | 281302 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-30 |