MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-10-13 for MULTI-DRUG 7 PANEL INTEGRATED CUP DOA-177-031-08A-ONW24A manufactured by Alere San Diego, Inc..
[57452279]
Investigation conclusion: further investigation cannot be pursued because there is no lot number. Fda medwatch report # mw5064340.
Patient Sequence No: 1, Text Type: N, H10
[57452280]
Received medwatch report: unconfirmed fp result x2, analyte not specified. The customer alleges two false positive results on the medwatch form under product code "enzyme immunoassay, cocaine metabolites (dio)". Reporter was a patient who claims the icup provided two (2) erroneously reported drug test results which led to two (2) incarcerations and the loss of two (2) professional licenses. Report did not state the incorrect drug/analyte. The following was included in the medwarch report: catalog number i-doa-177-031, event date (b)(6) 2014, event type injury, event description: the "icup" point of care test device is marketed such that the result is supposed to not be subjective and/or require any interpretation of the results. However, with this particular device, the result appears as a "red line". However, this is not made clear enough in the. The drug screen results were misinterpreted given the fact that this device is 510(k) cleared, but still requires interpretation of the result which defeats the entire purpose. There are untrained, unqualified individuals interpreting complex toxicology results and interpreting these themselves. This resulted in 2 erroneously reported drug test results. This then led to 2 incarcerations which are now on my record, the results were leaked to my 2 professional licensing boards who used these results to investigate me, suspend each license for 18 months and then permanently revoke both of these - my livelihood is taken away. Further, each result was used to substantiate a criminal charge. In total i spent 45 days incarcerated, have 2 criminal charges, lost my 2 professional licenses and am living off (b)(6). I have not worked in 3 years and this is the fault of this device which is not marketed properly and should not be waived! There is a problem with this particular drug screen device in that it does not make clear the cross reactivity of a specific product-nasal decongestant nasal inhaler. The product monograph is written in 6 point font of smaller and is almost impossible to see visually. They do have listed l-ephedrine on the non-cross reactivity list. The first issue is that the drug has been renamed a number of years ago - at least 10 years - and is now named l-levmetamfetamine. This is the first point of confusion. Second, it is listed as non-cross reactive when in fact this is not the case, and it does cross react with this drug product when used at the recommended dosage. There is no information provided on this by the manufacturer which is severely lacking and deceptive to the public. Incarceration, revocation of professional licenses, substantiation of criminal charges, false reporting of a relapse.
Patient Sequence No: 1, Text Type: D, B5
[62547156]
Investigation/conclusion: our case (b)(4) customer's complaint of unconfirmed fp results x2 for analyte not specified for multi-drug 7 panel integrated cup: further investigation cannot be pursued for this complaint because there was no lot number provided. Our case (b)(4) customer alleging the package insert was illegible due to the small font size. This complaint was a non-reportable event. However, the complaint was investigated: investigation revealed the customer's complaint was not replicated during inspection of the associated product insert. The product insert for this product was reviewed and it appeared legible. There are no known restrictions or guidance regarding pi font size for professional use products. No problem was found. Our case (b)(4) customer alleges incorrect cross-reactivity in the pi for l-ephedrine, customer states it is now named l-levamfetamine and cross-reacts with the test - analyte not specified. This was a non-reportable event. However, the complaint was investigated. Investigation revealed that the drug l -[? ]-ephedrine was renamed to l-levamfetamine. L -[? ]-ephedrine and l-levamfetamine belong to a different classes of drugs and have different structures. The customer also reported that l -[? ]-ephedrine cross-reacts with the test. Based on information provided in the pi, l -[? ]-ephedrine is listed in the non cross-reacting compounds. No problem was found. Based on the information available, there is no indication of a product deficiency. No corrective action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2016-00651 |
| MDR Report Key | 6028717 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2016-10-13 |
| Date of Report | 2016-09-19 |
| Date of Event | 2014-10-10 |
| Date Mfgr Received | 2016-11-17 |
| Date Added to Maude | 2016-10-13 |
| 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 ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI-DRUG 7 PANEL INTEGRATED CUP |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | DKZ |
| Date Received | 2016-10-13 |
| Model Number | DOA-177-031-08A-ONW24A |
| 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 ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-13 |