MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-08 for ALERE CHOLESTECH LDX MULTIANLYTE CONTROLS 88773 manufactured by Alere San Diego, Inc..
[32955240]
Control lot (c3091a) was associated with field action per capa-(b)(4) for incorrect expected value card provided with this control lot with the incorrect concentration assignment ranges for the total cholesterol and triglycerides analytes. No further investigation will be pursued under this case.
Patient Sequence No: 1, Text Type: N, H10
[32955241]
Report received of controls outside of expected range high 1x for trg on l2. Trg=312 (range: 206-304). No comparative data submitted. No reported adverse patient sequela. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2015-00990 |
| MDR Report Key | 5274879 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-08 |
| Date of Report | 2015-09-18 |
| Date of Event | 2015-09-18 |
| Date Mfgr Received | 2015-09-18 |
| Date Added to Maude | 2015-12-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2027969-08/25/15-001C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE CHOLESTECH LDX MULTIANLYTE CONTROLS |
| Generic Name | MULTI-ANALYTE CONTROLS |
| Product Code | JJY |
| Date Received | 2015-12-08 |
| Model Number | 88773 |
| Lot Number | C3091A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-08 |