MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-02 for ALERE CHOLESTECH LDX MULTIANALYTE CONTROLS 88773 manufactured by Alere San Diego, Inc..
[27650076]
Mdr is being filed due to field action: ref-2027969-08/25/15-001c. Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[27650077]
Customer reported that controls were outside of the expected range - high. Results were as follows: tc high two times for l1. Tc=160, 157 (108-152); trg=132 (129-191). The results were within the corrected expected values. Technical service reviewed factors and informed customer of notification; provided corrected expected values ranges and emailed the notification to the customer.
Patient Sequence No: 1, Text Type: D, B5
[33032345]
Control lot c3091a was associated with field action per internal (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. Investigation will be performed under internal (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2015-00825 |
| MDR Report Key | 5125624 |
| Date Received | 2015-10-02 |
| Date of Report | 2015-09-04 |
| Date of Event | 2015-09-04 |
| Date Mfgr Received | 2015-10-08 |
| Date Added to Maude | 2015-10-02 |
| 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 | DIETICIAN |
| 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 RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Manufacturer G1 | ALERE SAN DIEGO, INC. |
| Manufacturer Street | 9975 SUMMERS RIDGE RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2027969-08/25/15-001C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE CHOLESTECH LDX MULTIANALYTE CONTROLS |
| Generic Name | MULTI-ANALYTE CONTROLS |
| Product Code | JJY |
| Date Received | 2015-10-02 |
| Model Number | 88773 |
| Lot Number | C3091A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-02 |