MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-22 for ICHEM 100 800-7005 manufactured by Iris International.
[16013093]
False positive leukocyte esterase was reported on 101 pt results which lead to 12 pts to receive unnecessary antibiotics. The malfunction was confirmed by urine microscopy and urine cultures which were negative for urinary tract infection in all 12 pts.
Patient Sequence No: 1, Text Type: D, B5
[16284720]
Iris product ifu insert states that the diagnostic or therapeutic decisions should not be based on any single result or method. Therefore decision of clinician to administer therapy based on single false positive or false negative result is indicative of uses of device off labeled claim. The following mdrs are related to this event: 2023446-2013-00001, 2023446-2013-0003, 0004, 0005, 0006, 0007, 0008, 0009, 0010, 0011, 0012, 0013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2013-00012 |
| MDR Report Key | 3748618 |
| Report Source | 05 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-08-15 |
| Date Mfgr Received | 2013-08-15 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-05-08 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICHEM 100 |
| Generic Name | URINE CHEMISTY STRIPS |
| Product Code | JJW |
| Date Received | 2013-11-22 |
| Model Number | 800-7005 |
| Lot Number | 510034A |
| Device Expiration Date | 2015-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL |
| Manufacturer Address | CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-22 |