MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-07 for BD DIRECTIGEN MENINGITIS COMBO TEST KIT 252360 manufactured by Bd Diagnostics.
[923137]
A hospital in another country, was utilizing the bd directigen meningitis combo test kit (dmck). The lab tested two spinal fluid samples from a newborn with the dmck kit and got a positive result for neisseria meningitidis type a. The culture grew out enterobacter cloacae. The customer also directly tested the organism with the kit and a positive result with neisseria meningitidis type a was obtained. The newborn was already being treated for a positive blood culture infection when the csf was first collected due to the beginning of neurological symptoms. No change in treatment occurred due to dmck response. The directigen meningitis combo test is a presumptive latex agglutination test for the direct qualitative detection of antigens to h. Influenzae type b, s. Pneumoniae, n. Meningitidis groups a, b, c, y or w135 and escherichia coli k1 in cerebrospinal fluid (csf), serum or urine. The test can also be used for the direct qualitative detection of antigens.
Patient Sequence No: 1, Text Type: D, B5
[7886568]
No returns of the kit or the organism were available from the customer. Troubleshooting with customer did reveal that the customer centrifuged the sample at 1. 400rpm rather than 1400g. Centrifugation at 1400g for 10 minutes is done to remove cellular debris and the supernatant is then tested. Retention kit was examined. Three stains of enterobacter cloacae (atcc strains 13047, 35030 and 23355) were tested using isolated colonies per the package insert instructions. All results were satisfactory. No interactions were observed with neisseria meningitidis type a. The batch history record was reviewed with acceptable results. Bd will continue to monitor this product for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2008-00010 |
| MDR Report Key | 1100908 |
| Report Source | 05 |
| Date Received | 2008-08-07 |
| Date of Report | 2008-08-07 |
| Date of Event | 2008-05-27 |
| Date Mfgr Received | 2008-07-10 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2008-08-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JIM TILLMAN |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164054 |
| Manufacturer G1 | BECTON, DICKINSON |
| Manufacturer Street | 250 SCHILLING CIRCLE |
| Manufacturer City | COCKEYSVILLE MD 21030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21030 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD DIRECTIGEN MENINGITIS COMBO TEST KIT |
| Product Code | GTJ |
| Date Received | 2008-08-07 |
| Catalog Number | 252360 |
| Lot Number | 8052038 |
| Device Expiration Date | 2008-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1092943 |
| Manufacturer | BD DIAGNOSTICS |
| Manufacturer Address | 250 SCHILLING CIRCLE COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-08-07 |