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 2017-10-24 for COBAS INTEGRA 400 PLUS I400+ 03245233001 manufactured by Roche Diagnostics.
[90855574]
(b)(4). The event occurred in:(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[90855575]
The customer complained of questionable results for vanc for two patient samples. For patient #1 the initial vancomycin result was 37. 81 mg/l. On (b)(6) 2017 the sample was repeated twice with results of 16. 59 mg/l and 16. 39 mg/l. It is unknown if the questionable result for patient #1 was reported outside of the laboratory. The repeat results were deemed to be correct. It is unknown if there was any adverse event. For patient #2 the initial vancomycin result obtained on (b)(6) 2017 was 35. 90? G/ml. On (b)(6)2017 the same sample was repeated with results of 75. 33? G/ml and 75. 72? G/ml. For patient #2 the repeat results were deemed to be correct. Additional information for patient #2 has been requested. The vancomycin reagent lot was 25482301 with and expiration date of 30-sep-2018. The field service representative performed preventive maintenance and replaced solenoid valves. Since calibrations and qc around the time of events are acceptable a reagent and system issue can be excluded. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02404 |
| MDR Report Key | 6971020 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-24 |
| Date of Report | 2017-11-16 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-10-03 |
| Date Added to Maude | 2017-10-24 |
| 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 | 0 |
| 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 | LEH |
| Date Received | 2017-10-24 |
| Model Number | I400+ |
| Catalog Number | 03245233001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-24 |