MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2015-12-21 for MULTISTIX 10SG 10627148 manufactured by .
[34018832]
Siemens investigated customer returned multistix 10sg strips. Performance of the submitted reagent strips was tested by visual method using both a negative and a 0. 0621 mg/dl (positive) ob solution. Testing was performed by two (2) qualified readers in a macbeth lightbox under cool white fluorescent lighting. Each reader assessed six (6) strips per test solution. Ob reagent is read at 60 seconds after dipping. Visual testing is quantified by assigning a numeric designation (nd) to the color appearance of the tested reagent against a standard. All values for both test solutions (both readers) reported in the expected ranges:? No color development was noted for the strips tested with the negative solution. ? Strips tested with the 0. 0621 mg/dl (positive) solution developed the characteristic green color to average greater or equal to 30 nd and matched the small (positive) color block printed on the reagent strip label. Conclusion: the customer observation of false negative ob results when visual testing with multistix 10sg reagent lot 501032, as reported in complaint, was not reproduced.
Patient Sequence No: 1, Text Type: N, H10
[34018833]
Customer reported false negative blood results when they read visually on multistix 10sg. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2015-00188 |
| MDR Report Key | 5315356 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2015-12-21 |
| Date of Report | 2015-12-21 |
| Date of Event | 2015-12-04 |
| Date Mfgr Received | 2015-12-04 |
| Date Added to Maude | 2015-12-21 |
| 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 | 3 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | KIMBALL ELECRONICS |
| Manufacturer Street | UL. POZENANSKA 1/C POLAND SP.Z O.O |
| Manufacturer City | TARNOWO PODGORNE, 62080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTISTIX 10SG |
| Generic Name | MULTISTIX 10SG |
| Product Code | JIR |
| Date Received | 2015-12-21 |
| Catalog Number | 10627148 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-21 |