MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-07-02 for CHROMID S. AUREUS 43371 manufactured by Biom?rieux Sa.
[6066279]
A customer in (b)(6) reported a false negative result with chromid (b)(6) agar (ref. 43371, lot 1003864180, expiration 08-jul-2015). The customer stated that colonies of (b)(6) organism did not develop any color. As stated in the ifu (instruction for the use), the colonies of (b)(6) organism should be very pale green to dark green in color. The customer then sub-cultured the organism colonies from the incriminated chromid (b)(6) plates onto a different lot number (1003938520) of chromid (b)(6) agar plates. After incubation, organism colonies produced are green in color.. No information has been provided regarding patient prescribed therapy, or if the discrepant negative chromid (b)(6) agar result impacted treatment decisions. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. Culture submittals have been requested for internal investigation.
Patient Sequence No: 1, Text Type: D, B5
[13958222]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[37289862]
An investigation was conducted to verify the conformity of the implicated batch 1003864180, chromid s. Aureus agar, ref (b)(4). For this batch number, the customer observed a growth of a staphylococcus aureus with no typical green colony color. Submittal of the patient isolate(s) was requested by biom? Rieux; however, the customer did not comply. Review of complaint records indicates no other complaint registered against this reference number and batch number. Review of the batch record confirmed that no anomaly was detected during manufacturing or quality control testing to explain the issue reported by the customer. For the release of the batch after its manufacturing, the results of the microbiological quality control are in accordance with specifications. The investigation included retained samples of the customer batch of chromid s. Aureus (1003864180), in parallel with another batch of chromid s. Aureus agar (1003938520, expiry date 06aug15), using the same strains as used during product release tests. After an incubation of 20-24h, the strain of s. Aureus atcc 6538 presents green colonies, with the same results for both batches. The strain of s. Aureus atcc 25923 presents green colonies in the mass; the isolated colonies are pale green to colorless for the "reference" batch and colorless for the customer batch. After an incubation of 48h all the results are correct for the reference batch and the customer batch : good growth of staphylococcus aureus atcc 25923 with characteristic green colonies. Good growth of staphylococcus aureus atcc 6538 with characteristic green colonies. Since the customer did not provide a submittal of the patient strain, no further testing is possible to identify if the strain meets any of the limitations indicated in the instructions for use (package insert 43371). The investigation concluded that the performance of chromid s. Aureus agar ref (b)(4), batch 1003864180 is within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00053 |
| MDR Report Key | 4888163 |
| Report Source | 01,05,06 |
| Date Received | 2015-07-02 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-06-16 |
| Device Manufacturer Date | 2015-03-18 |
| Date Added to Maude | 2015-07-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID S. AUREUS |
| Generic Name | CHROMID S. AUREUS |
| Product Code | JWX |
| Date Received | 2015-07-02 |
| Catalog Number | 43371 |
| Lot Number | 1003864180 |
| Device Expiration Date | 2015-07-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-02 |