MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for CHLORIDE ELECTRODE 03246353001 manufactured by Roche Diagnostics Operations Inc..
[126635958]
Quality control (qc) results were unacceptable after installation of multiple lots of roche diagnostics cobas chloride electrodes (cat # 03246353001). Roche sent a product bulletin on (b)(6) 2018 (tp-00394; chloride electrodes - discontinue use of certain lots). However, we have observed this qc issue on numerous lots not listed in the product bulletin. Chloride electrode lots which did not pass qc criteria at our institute include: a2072, b0625, b0094, a3760, w5233, x1881, x1882, x6230, y7004, y7200, and y8413. Affected electrodes were not placed into clinical use by our lab, therefore no pt results have been affected at our facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081091 |
| MDR Report Key | 8042449 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-02 |
| Date Added to Maude | 2018-11-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | A2072 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | B0625 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | B0094 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | A3760 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS, INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | W5233 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS, INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | X1881 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS, INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | X1882 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 7 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS, INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | X6230 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 8 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS, INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | Y7004 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 9 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS, INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | Y7200 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 10 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS, INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | CHLORIDE ELECTRODE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-11-05 |
| Catalog Number | 03246353001 |
| Lot Number | Y8413 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 11 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS, INC. |
| Manufacturer Address | INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-05 |