MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-03-27 for COBAS PCR URINE SAMPLE KIT 05170486190 manufactured by Roche Molecular Systems.
[3323554]
On (b)(6) 2013, a doctor from (b)(6) hospital, (b)(6) called roche to report that a young child had been admitted to the hospital after ingesting pcr media form the urine collection tube contained in the cobas pcr urine sample kit (m/n 05170486190). Although repeated follow up attempts were made to contact the doctor to obtain further information regarding the incident and condition of the child, no additional information is available. It is unknown how the child came into contact with and ingested the pcr media.
Patient Sequence No: 1, Text Type: D, B5
[10608750]
Result - child ingested liquid media from a reagent kit. Conclusion - child ingested liquid media from a reagent kit. Although repeated follow up attempts were made to contact the doctor to obtain further information regarding the incident and condition of the child, no additional information is available. The cobas pcr urine sample kit package insert states the following in the warnings and precautions section: avoid contact of the cobas pcr media with the skin, eyes or mucous membranes. If contact does occur, immediately wash with large amounts of water. Cobas pcr media 1 x 4. 3 ml contains: < = 40% (w/w) guanidine hydrochloride, tris-hcl buffer, xn 25- 50% (w/w) guanidine hcl. R: 22-36/38 harmful if swallowed. Irritating to eyes and skin. S: 13-26-36-46 keep away from food, drink and animal feeding stuffs. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing. If swallowed, seek medical advice immediately and show this container or label. The material safety data sheet (msds) for cobas pcr urine sample kit identifies the following hazards and first aid measures for ingestion: ingestion: harmful if swallowed. Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea. Medical conditions aggravated by exposure: none known. First aid measures for ingestion: consult a physician. Do not induce vomiting without medical advice. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00005 |
| MDR Report Key | 3023983 |
| Report Source | 01 |
| Date Received | 2013-03-27 |
| Date of Report | 2013-03-01 |
| Date of Event | 2013-03-01 |
| Date Mfgr Received | 2013-03-01 |
| Date Added to Maude | 2013-03-27 |
| 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 | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS PCR URINE SAMPLE KIT |
| Generic Name | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA |
| Product Code | MKZ |
| Date Received | 2013-03-27 |
| Catalog Number | 05170486190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-03-27 |