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 2017-10-23 for GLUC3 GLUCOSE HK GEN.3 04404483190 manufactured by Roche Diagnostics.
[90797642]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90797643]
The customer stated that they received erroneous results for one patient sample tested for gluc3 glucose hk gen. 3 (glu) on two cobas integra 400 plus (i400+) analyzers. An erroneous result was reported outside of the laboratory. The sample was measured several times on two i400+ analyzers and the results were approximately 6 to 7 mg/dl. The sample was measured with a glucometer and the results were approximately 97 to 107 mg/dl. The customer collected a new sample from the patient and repeated measurements on an i400+ analyzer. The customer measured different tubes of this sample consisting of different sample material (serum, plasma, serum collected from capillary blood). All results were comparable. It was asked, but it is not known if any adverse events occurred. No adverse events were alleged to have occurred with the patient. The serial numbers of the i400+ analyzers were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02396 |
| MDR Report Key | 6968329 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-23 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-10-02 |
| Date Mfgr Received | 2017-10-02 |
| Date Added to Maude | 2017-10-23 |
| 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 | GLUC3 GLUCOSE HK GEN.3 |
| Generic Name | HEXOKINASE, GLUCOSE |
| Product Code | CFR |
| Date Received | 2017-10-23 |
| Model Number | NA |
| Catalog Number | 04404483190 |
| Lot Number | ASKU |
| 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 | 2017-10-23 |