MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-07-07 for STERICHEK TOTAL CHLORINE REAGENT STRIP * manufactured by Environmental Test Systems.
[148172]
A test strip for measuring low chlorine levels in water used to prepare solutions for kidney dialysis gave falsely low values in the presence of very high levels of chlorine. The tested water came from a holding tank that had been sanitized with chlorine the night before. On june 27, 2000, a voice mail referred to a "problem" with the new reagent strip for low range chlorine. On june 28, co learned that two persons undergoing kidney dialysis became ill because the water used to make the dialysis solution contained chlorine. The dialysis center personnel checked the solution with a test strip designed to measure higher levels of chlorine and showed that there was chlorine present in the solution. There was intervention by dialysis center personnel and the pts have not suffered permanent injury. They are described as fine. The above info is based on telephone conversations. The dialysis center has not yet provided a written report to the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1833407-2000-00001 |
| MDR Report Key | 284977 |
| Report Source | 06 |
| Date Received | 2000-07-07 |
| Date of Report | 2000-07-07 |
| Date of Event | 2000-06-22 |
| Date Mfgr Received | 2000-06-28 |
| Device Manufacturer Date | 2000-04-01 |
| Date Added to Maude | 2000-07-11 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID MORRIS |
| Manufacturer Street | 23575 C.R. 106 |
| Manufacturer City | ELKHART IN 46514 |
| Manufacturer Country | US |
| Manufacturer Postal | 46514 |
| Manufacturer Phone | 2192622060 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERICHEK TOTAL CHLORINE REAGENT STRIP |
| Generic Name | REAGENT STRIP FOR WATER TESTING |
| Product Code | DJW |
| Date Received | 2000-07-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 003040 |
| ID Number | * |
| Device Expiration Date | 2002-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 275782 |
| Manufacturer | ENVIRONMENTAL TEST SYSTEMS |
| Manufacturer Address | 23575 C. R. 106 ELKHART IN 46514 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-07-07 |