MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-17 for API? RAPID 20E 20701 manufactured by Biomerieux, Sa.
[65468821]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[65468822]
A customer in (b)(6) reported they observed a low sugar reaction, leading to potential organism misidentification, for a urine specimen in association with the api? Rapid 20e test. The bacteria identified by vitek? 2 were cloacae and serratia. The customer stated that no discrepant result was reported to a physician and that patient treatment was not impacted. The customer stated there was a one-day delay in reporting results. There may be a potential for adverse event if the event were to reoccur; therefore this event is being reported as a malfunction. Culture submittals have been requested by biom? Rieux for internal investigation. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[74515711]
An internal biom? Rieux investigation was performed. The quality control laboratory tested the atcc strains referenced in the rapid 20 e package insert: o escherichia coli atcc 11775. O klebsiella pneumoniae atcc 35657. O proteus vulgaris. Testing was completed on retained samples available at the manufacturing site (lot 1004905250) and from the customer site. The retained manufacturing site lot conform to internal specifications. The customer's complaint could not be reproduced on this lot. Testing on the customers lot also conform to internal specifications. The customer's complaint could not be reproduced on this lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2017-00005 |
| MDR Report Key | 6258014 |
| Date Received | 2017-01-17 |
| Date of Report | 2017-04-19 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2016-05-27 |
| Date Added to Maude | 2017-01-17 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME LES GROTTES ISERE, 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | API? RAPID 20E |
| Generic Name | API? RAPID 20E |
| Product Code | JSS |
| Date Received | 2017-01-17 |
| Catalog Number | 20701 |
| Lot Number | 1004905250 |
| Device Expiration Date | 2017-11-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, SA |
| Manufacturer Address | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE, 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-17 |