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 2017-09-15 for COBAS INTEGRA 400 PLUS I400+ manufactured by Roche Diagnostics.
[86601735]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4) medwatch phone number was provided as (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[86601736]
The customer stated that they received erroneous results for one patient sample tested for gluc3 glucose hk (gluc) on an cobas integra 400 plus (i400+). The erroneous results were not reported outside of the laboratory. The sample had a low volume. The sample initially resulted as 234. 7 mg/dl. The sample was repeated twice, resulting as 286 mg/dl and 158. 5 mg/dl respectively. The third repeat result was 162 mg/dl, which was considered to be correct and reported outside of the laboratory. No adverse events were alleged to have occurred with the patient. The gluc reagent lot number was 236290. The reagent expiration date was asked for, but not provided. The field service engineer checked the analyzer hardware and sample probe. These were ok. The gluc assay was successfully calibrated on (b)(6) 2017. Between 19-aug-2017 and 27-aug-2017, the level 1 quality control was within range, but there was a large variation in results. Between 27-aug-2017 and 29-aug-2017, the level 1 quality control was close to target and showed higher precision. The level 2 quality control was within range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02004 |
| MDR Report Key | 6869134 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-15 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-08-25 |
| Date Mfgr Received | 2017-08-28 |
| Date Added to Maude | 2017-09-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFR |
| Date Received | 2017-09-15 |
| Model Number | I400+ |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-15 |
| Model Number | I400+ |
| Catalog Number | ASKU |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-15 |