MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-03-23 for ALBUSTIX 2807 manufactured by Kimball Electronics (wales) Ltd..
[17482743]
This event occurred in another country where the albustix product is distributed for professional use only. In this reported incident, a bottle of albustix, which is a urine strip product that measures protein, was given to the parents of a child with kidney disease, under the direction of the dr, so they could monitor the child's protein level at home. The parents were provided directions on how to use the albustix by the dr and were told that if the albustix results were positive three times continuously, the child should be brought back to the hosp. When the parents tested the child, the results showed a blue-green color, which on the albustix color chart is indicative of an elevated protein level. However, when the parents compared the test strip to the color code on the bottle label, this blue-green color matched a negative result. Because the child tired easily and his face was swollen, the parents thought some thing was wrong and discovered that the bottle label was incorrect. They took the child to the hosp and his protein tested at a level of 3+, which corresponds to an elevated protein level and is blue-green on the albustix color chart. It was found that the specific bottle of albustix that was given to the parents, had a glucose urine strip product label, not an albustix label. The color coding on the glucose bottle label for a negative glucose is the same blue-green color as an elevated protein level for the albustix product. When the parents compared the child's albustix test results to the color code on the bottle label, they interpreted the test results as negative when it was actually an elevated protein level.
Patient Sequence No: 1, Text Type: D, B5
[17663946]
Investigations with the mfr found that this issue was isolated to a specific packaging run of this lot (6g06a), which was solely distributed in another country. The mfr has implemented add'l line clearance and label inspections to prevent future occurrences. A notification has been sent to the siemens diagnostics customers in that country instructing them to discontinue the use of this lot. At this time there have been no add'l reported adverse events for this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2007-00009 |
| MDR Report Key | 833050 |
| Report Source | 05,07 |
| Date Received | 2007-03-23 |
| Date of Report | 2007-02-28 |
| Date of Event | 2007-02-27 |
| Date Mfgr Received | 2007-02-28 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2007-04-03 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 5086608540 |
| Manufacturer G1 | KIMBALL ELECTRONICS (WALES) LTD. |
| Manufacturer Street | BRIDGEND INDUSTRIAL ESTATE BRIDGEND |
| Manufacturer City | WALES CF313TY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF31 3TY |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALBUSTIX |
| Generic Name | URINALYSIS STRIP |
| Product Code | JIR |
| Date Received | 2007-03-23 |
| Model Number | NA |
| Catalog Number | 2807 |
| Lot Number | 6G06A |
| ID Number | * |
| Device Expiration Date | 2009-04-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 820355 |
| Manufacturer | KIMBALL ELECTRONICS (WALES) LTD. |
| Manufacturer Address | BRIDGEND INDUSTRIAL ESTATE BRIDGEND WALES UK CF31 3T |
| Baseline Brand Name | ALBUSTIX |
| Baseline Generic Name | URINALYSIS STRIP |
| Baseline Model No | NA |
| Baseline Catalog No | 2807 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-23 |