MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for MRSASELECTII 63758 manufactured by Bio-rad Laboratories.
[112157962]
Patient Sequence No: 1, Text Type: N, H10
[112157963]
On (b)(6) 2018, (b)(6) laboratories - (b)(4) operations was made aware of an issue with (b)(6) select and (b)(6) selectii media plates. These products are selective and differential chromogenic media for the qualitative detection of (b)(6) colonies. Following reports from three customers located outside of the u. S. , concerning an abnormal coloration of certain agar plates and the growth of non-characteristic (b)(6) colonies, bio-rad laboratories (infectious disease division, located in (b)(4)) conducted an investigation and confirmed that certain lots may be at risk for this issue. To date, (b)(6) laboratories infectious disease division has identified the following key features of this product issue: the origin of the problem is isolated to certain raw materials. The observation of a non-characteristic coloration of agar and non-characteristic (b)(6) colonies (colonies without any pink color development) occurs when the media plates have been exposed to light for prolonged periods during use and storage. For (b)(6) select, the issue presents after exposure periods greater than 2 hours. For (b)(6) select ii, the issue presents after exposure periods greater than 4 hours. Media plates with abnormal coloration may be visually identified by the user and may be detected prior to inoculation. If plates were exposed to light for time periods exceeding those stated above, then (b)(6) colonies may appear white to yellow instead of the pink characteristic color, or colony growth may be delayed. As a result, there is a risk of misinterpretation of the result (possible (b)(6)). In order to mitigate risk to results, bio-rad laboratories has recommended the following actions to all customers, distributed in the form of a customer letter: -as already recommended in the package insert, please ensure that exposure of agar plates to light is minimized, both before and during incubation, with the added time restrictions as follows: for (b)(6) select, do not expose the agar plates to light for more than 2 hours during storage, warming, incubation, and reading. For (b)(6) selectii, do not expose the agar plates to light for more than 4 hours during storage, warming, incubation, and reading. ? Do not use agar with a change in color from white to an orange-pinkish shade. ? As recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or pastorex staph-plus. The initial complaint was received from a customer in (b)(6) on the outside-u. S. Version of (b)(6) select ii (cat. No. 63759). A subsequent complaint was received from a (b)(6) customer on the outside-u. S version of (b)(6) select (cat. No. 63757). Therefore, bio-rad is filing two u. S. Mdr reports for the u. S. Version of (b)(6) select and (b)(6) selectii (cat no. 63747 and 63758, respectively) even though no incidents were reported involving u. S. Versions of these devices. This decision is made as per section 4. 11. 3 of the fda guidance "medical device reporting for manufacturers," which states that an event that occurs in a foreign country is reportable if the device in question is similar to a device cleared in the u. S. Investigation at the bio-rad laboratories (b)(4) location, which occurred subsequent to the initial complaint, has indicated that raw materials implicated in the enhanced light sensitivity issue were also used in both (b)(6) select and (b)(6) select ii products distributed both outside-u. S. And within u. S. Although no complaints have been received against the u. S. Version of (b)(6) selectii (cat. No. 63758), this report is being submitted in order to exercise an abundance of caution and to satisfy the requirement as described in section 4. 11. 3 of the aforementioned guidance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022521-2018-00006 |
| MDR Report Key | 7607927 |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-05-30 |
| Date Added to Maude | 2018-06-15 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID BHEND |
| Manufacturer Street | 6565 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981758 |
| Manufacturer G1 | BIO-RAD LABORATORIES |
| Manufacturer Street | 3, BOULEVARD RAYMOND POINCARE |
| Manufacturer City | MARNES-LA-COQUETTE, 92430 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MRSASELECTII |
| Generic Name | MRSASELECTII |
| Product Code | JSO |
| Date Received | 2018-06-15 |
| Catalog Number | 63758 |
| Lot Number | 64177778 |
| Device Expiration Date | 2018-06-10 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 3, BOULEVARD RAYMOND POINCARE MARNES-LA-COQUETTE, 92430 FR 92430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-15 |