MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-11 for ICHEM VELOCITY CONTROL manufactured by Iris Intl.
[14878440]
Customer getting discordant results with 20 patients between ichem velocity (negative) and iq200 (positive). Customer reported that one patient sample was negative on chemistry and had >45 rbc's. The other 19 patient samples were also negative on chemistry and had approximately 5 rbc's. The presence of rbc's was confirmed with manual microscope in all patients.
Patient Sequence No: 1, Text Type: D, B5
[15283943]
(b)(4). Iris product ifu insert states that the diagnostic or therapeutic decisions should not be based on any single result or method. No reports of change in patient management or injuries were reported. The following mdrs are related to this event. 2023446-2013-0024, -00025, -00026, -00027, -00028, -00029, -00030, -00031, -00032, -00033, -0034, -00035, -00036, -00037, -00038, -00039, -00040, -00041, -00042.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2013-00041 |
| MDR Report Key | 3636163 |
| Report Source | 05 |
| Date Received | 2013-12-11 |
| Date of Report | 2013-12-11 |
| Date of Event | 2013-08-31 |
| Date Mfgr Received | 2013-08-31 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-03-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUDHA GUPTA |
| Manufacturer Street | 9172 ETON AVE. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277497 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICHEM VELOCITY CONTROL |
| Generic Name | ICHEM VELOCITY CONTROL |
| Product Code | JJW |
| Date Received | 2013-12-11 |
| Lot Number | 213-13 |
| ID Number | 800-7704, 800-7217 |
| Device Expiration Date | 2014-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTL |
| Manufacturer Address | CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-11 |