MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-05 for IQ200 AUTOMATED URINALYSIS SYSTEM 700-3347 manufactured by Iris International.
[56549931]
A field service engineer (fse) was dispatched on (b)(6) 2016 and replaced the sample filter and tubing. The fse also adjusted the calumniation of the flowcell. The fse reported that he did not reproduce the issue or identify an instrument malfunction that could have caused the issue. The fse stated that he could not conclude a cause of event. The cause of the event is unknown. It is unknown based on the information available whether the customer was following the correct labelling instructions on classification of bacterial cells. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[56549932]
The customer reported false negative bacteria results from an iq200 automated urinalysis system despite positive nitrite chemistry results on three (3) patient samples. The customer reported that bacteria was present upon manual microscopic examination of the samples, but that urine cultures were not performed due to the false negative bacteria results. The erroneous results were reported out of the laboratory for three (3) patients; however, the customer reported there was no change or affect to patient treatment in conjunction with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023446-2016-00381 |
| MDR Report Key | 6001041 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-05 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-09-12 |
| Date Mfgr Received | 2016-09-12 |
| Device Manufacturer Date | 2013-03-22 |
| Date Added to Maude | 2016-10-05 |
| 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 | GOPAL MOHANTY |
| Manufacturer Street | 9172 ETON AVENUE |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277379 |
| Manufacturer G1 | IRIS INTERNATIONAL |
| Manufacturer Street | 9172 ETON AVE |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IQ200 AUTOMATED URINALYSIS SYSTEM |
| Generic Name | COUNTER, URINE PARTICLE |
| Product Code | LKM |
| Date Received | 2016-10-05 |
| Model Number | NA |
| Catalog Number | 700-3347 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL |
| Manufacturer Address | 9172 ETON AVE CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-05 |