MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-13 for TRIAGE METERPRO DOMESTIC KIT 55070 manufactured by Alere San Diego, Inc..
[31416784]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[31416785]
A customer in (b)(6) reported potential false positive results on all analytes when testing the triage tox drug screen panel (25t). Customer reported that they were setting up a new triage meter and ran a known negative sample (water) that gave positive results for all analytes. While testing the meter, the customer suspected that there may be something in the settings causing the problem. (note: this mdr filing is due to the device being the same or similar as a device available in the us).
Patient Sequence No: 1, Text Type: D, B5
[39558734]
Corrections: brand name: removed triage tox drug panel (25t), as complaint device and added the triage meterpro domestic kit (meter). Model #: removed tox penal number (94400eu) and included the meter serial # ((b)(4)). Concomitant medical products: removed the meter as the concomitant medical product and included the triage tox drug screen panel. The 510(k)#: removed the 510(k) # for the tox drug screen panel and included the one for the meterpro kit ((b)(4)). Labeled for single use: changed from 'yes' to 'no' since the meter is not a single use device. Usage of device: changed from 'unknown' to 'reuse' since the meter is not a single use device. Manufacturer narrative: customer's complaint of false positive results for all analytes was replicated with the returned meter only. In-house meters did not produce erroneous results with the same devices/panels tested on the returned meter. Issue appears to be related to the returned meter. Reviewed the batch record for tox lot w60458rb; the lot passed ous release specifications. During the investigation, it was found the returned meter had incorrectly set analyte threshold ranges by the customer's data management software. No other complaints have been reported for this issue. No further investigation will be pursued. No product deficiency was established with tox lot w60458; no corrective action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2015-00928 |
| MDR Report Key | 5221896 |
| Date Received | 2015-11-13 |
| Date of Report | 2015-10-16 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2016-02-02 |
| Date Added to Maude | 2015-11-13 |
| 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 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE METERPRO DOMESTIC KIT |
| Generic Name | DOA DRUG SCREEN TEST |
| Product Code | DJR |
| Date Received | 2015-11-13 |
| Returned To Mfg | 2015-10-26 |
| Model Number | 55070 |
| Lot Number | W60458R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-11-13 |