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 2018-11-07 for GLUC2 GLUCOSE HK 20767131322 manufactured by Roche Diagnostics.
[128259801]
This event occurred in (b)(6). Phone was provided as (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[128259802]
The customer received questionable low gluc3 glucose hk gen. 2 results for one patient from two cobas 6000 c501 modules. Only one serial number ((b)(4)) was provided. The patient was not responsive at the dentist and when the ambulance arrived, the patient became responsive again but was taken to hospital. At the hospital, for the first sample the glucose results from two different cobas 6000 analyzers were 11 mg/dl and 4 mg/dl. The result from a bga system for a different tube from for the same draw was 90 mg/dl. For a second sample, the glucose results from two different cobas 6000 analyzers were 47 mg/dl and 43 mg/dl. The result from a bga system for a different tube from for the same draw was 102 mg/dl. The result from a poct- bz system was 89 mg/dl. For a third sample, the glucose results from two different cobas 6000 analyzers 93 mg/dl and 95 mg/dl. All of the results were reported outside of the laboratory. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04120 |
| MDR Report Key | 8045772 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-07 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-19 |
| Date Added to Maude | 2018-11-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | GLUC2 GLUCOSE HK |
| Generic Name | HEXOKINASE, GLUCOSE |
| Product Code | CFR |
| Date Received | 2018-11-07 |
| Model Number | NA |
| Catalog Number | 20767131322 |
| Lot Number | 336546 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-11-07 |